Encapsulated functional food compositions

ABSTRACT

A functional food composition comprising an edible or potable substance, a cross-linked edible matrix encapsulating the edible or potable substance, a probiotic, and a prebiotic, with the proviso that the edible or potable substance and the matrix do not both contain the probiotic or both contain the prebiotic. The encapsulated composition provides certain advantages in its transport, handling and consumption. The edible membrane matrix can be constructed to include edible particles that impart advantages to the performance of the membrane matrix, provide functional nutrition, health and well-being benefits, therapeutic treatment to the consumer, and/or enhance consumer gustatory experience. In particular aspects, the functional food composition provides nutritive and health benefits for disease treatment and prevention, and health maintenance through the incorporation of certain biologically active compounds in the edible substance and/or as particles in the membrane matrix.

RELATED APPLICATIONS

This application claims the benefit of U.S. Patent Application No.61/860,586, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,629, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,609, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,652, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,625, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,591, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,623, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,595, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,617, filed on Jul. 31, 2013, U.S. Patent Application No.61/860,599, filed on Jul. 31, 2013 and U.S. Patent Application No.61/947,803, filed on Mar. 4, 2014; the entire teachings of theseapplications are incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to functional food compositions, membraneencased edible compositions, and more particularly to fully encased,functional food compositions.

BACKGROUND

Functional foods provide nutritional components that are important forhealth maintenance. These food compositions contain compounds that arebiologically active or bioavailable, such as probiotics, amino acids,multivitamins, and antioxidants, and often are found to be useful forthe treatment of disease and disorders or the maintenance of normalhealth states. However, delivery systems for bioavailable compoundsoften can have insufficient viability, resulting in suboptimal bioactivequantities and bioavailability of these compounds. Many functionalcompounds are beneficial to hosts only when consumed in sufficientquantities. Therefore, consumers continually seek functional foodcompositions with enhanced effectiveness.

SUMMARY

This disclosure relates to a variety of functional food compositions.Functional food compositions are designed to deliver sufficientquantities and quality of bioactive and bioavailable compositions usingedible or potable substances encapsulated in an edible membrane matrix.The encapsulated composition provides certain advantages in itstransport, handling and consumption. The edible membrane matrix can beconstructed to include edible particles that impart advantages to theperformance of the membrane matrix, provide functional nutrition, healthand well-being benefits, therapeutic treatment to the consumer, and/orenhance consumer gustatory experience. In particular aspects, thefunctional food composition provides nutritive and health benefits fordisease treatment and prevention, and health maintenance through theincorporation of certain biologically active compounds in the ediblesubstance and/or as particles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, a probiotic, and aprebiotic, with the proviso that the edible or potable substance and thematrix do not both contain the probiotic or both contain the prebiotic.The matrix can comprise the prebiotic and the edible or potablesubstance component comprises the probiotic, or the matrix comprises theprobiotic and the edible or potable substance comprises the prebiotic.The functional food composition can comprise a probiotic concentrationfrom about 1.0 to about 100 billion colony forming units in anindividual edible transport vessel, and the probiotic can be an organismselected from the genera group consisting of Aspergillus, Bacillus,Bacteroides, Bifidobacterium, Brettanomyces, Enterococcum,Kluyveromyces, Lactobacillus, Lactococcus, Leuconostoc, Pediococcus,Propionibacterium, Saccharomyces, Shewanella, Streptococcus,Torulaspora, Vagococcus, and any derivatives, strains, and combinationsthereof.

The prebiotic of the functional food composition can be one of the groupconsisting of galacto-oligosaccharides, inulin, oligofructose,isomalto-oligosaccharides, lactulose, lactosucrose,transgalacto-oligosaccharides, soybean oligosaccharides, tagatose,xylo-oligosaccharides, and combinations thereof. The prebioticconcentration can be from about 1.0 to about 30.0 grams in an individualedible transport vessel.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The prebiotic, the probiotic, and/oradditional edible particles can provide enhanced performance to thematrix.

The prebiotic, the probiotic, and/or additional edible particles cancomprise a size having a volume mean distribution between about 0.1microns and about 1.0 microns, between about 0.1 microns and about 10.0microns, between about 0.1 microns and about 100.0 microns, betweenabout 0.1 microns and about 1.0 millimeters, or between about 0.1 andabout 3 millimeters.

The functional food composition can be used for the normalization ofgastro-intestinal flora in a subject, for the prevention and treatmentof a gastrointestinal disorder, for the prevention and treatment of asystemic disorder, to improve immune function, for improved digestion,and to decrease intestinal gas production.

Provided is a method for maintaining or improving digestive health byadministering to an individual in need thereof a functional foodcomposition as described herein. The functional food composition can beadministered in an amount sufficient to increase the gastrointestinalmicroflora concentration of an individual. The functional foodcomposition can be administered in an amount sufficient to increase thefecal microflora concentration of an individual. The functional foodcomposition can be administered in an amount sufficient to maintainnormal gastrointestinal microflora concentration of an individual. Thefunctional food composition can be administered in an amount sufficientto provide relief from gastrointestinal bloating of an individual.

Provided is a method for the prevention and treatment of agastrointestinal disorder by administering to an individual in needthereof a functional food composition as described herein, where thegastrointestinal disorder comprises at least one of the group comprisingdiarrhea, Traveler's Diarrhea, antibiotic-associated diarrhea,inflammatory bowel disease, excessive stomach acid, dyspepsia,constipation, irritable bowel syndrome, Crohn's Disease, lactoseintolerance, and pathogenic infection.

The functional food can be administered in an amount sufficient toprevent or treat the establishment of opportunistic gastrointestinalpathogens.

Provided is a method for the treatment of a systemic disorder byadministering to an individual in need thereof a functional foodcomposition as described herein, where the systemic disorder comprisesat least one of the group consisting of elevated cholesterol,hypertension, acid reflux disease, colon cancer, and obesity.

Provided is a method for improving immune response by administering toan individual in need thereof a functional food composition as describedherein, where improving immune response further comprises lowering theseverity of at least one of the group consisting of diarrhea, Traveler'sDiarrhea, antibiotic-associated diarrhea, inflammatory bowel disease,excessive stomach acid, dyspepsia, constipation, irritable bowelsyndrome, Crohn's Disease, lactose intolerance, and pathogenicinfection.

This disclosure also relates to the delivery of bioflavonoids, carotenesand elastic tissue components using edible or potable substancesencapsulated in an edible membrane matrix. In particular aspects, thefunctional food provides functionally nutritive benefits for integumentdisorder prevention and health, beauty and wellness maintenance throughthe incorporation of certain biologically active compounds in the ediblesubstance and/or as particles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, the cross-linked matrixcomprising an edible polymer, and an integument health compoundcomprising a bioflavonoid, a carotene, and an elastic tissue component.

The functional food composition can include a bioflavonoid derived fromat least one of the group consisting of Camellia sinensis, Theobromacacao, varieties thereof, strains thereof, cultivars thereof, andcombinations thereof.

The functional food composition can include bioflavonoid selected fromthe group consisting of esveratrol, quercetin, rutin, catechin,epicatechin, proanthocyanidin, cocoaflavanol, and combinations thereof.

The functional food composition can include an essential fatty acidselected from the group consisting of α-linolenic acid, eicosapentanoicacid, docosahexaenoic acid, and combinations thereof.

The functional food composition can include a carotene selected from thegroup consisting of α-carotene, β-carotene, γ-carotene, δ-carotene,ε-carotene, lycopene, and combinations thereof.

The functional food composition can include a connective tissuecomponent selected from the group consisting of collagen, elastin, andcombinations thereof.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The cardiovascular health compound and/oradditional edible particles can provide enhanced performance to thematrix.

The functional food composition of the integument health compound and/oradditional edible particles can have a size with a volume meandistribution between about 0.1 microns and about 1.0 microns, betweenabout 0.1 microns and about 10.0 microns, between about 0.1 microns andabout 100.0 microns, between about 0.1 microns and about 1.0millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible unpolymerized matrix, and an integument health compoundcomprising a bioflavonoid, a carotene, and an elastic tissue component,combining the edible or potable substance and/or the edibleunpolymerized matrix with the integument health compound, andencapsulating the edible substance with the edible matrix. The methodcan further comprise the step of polymerizing the edible matrix.

The functional food composition can be used for maintenance of skin, forthe maintenance of nails, for the maintenance of hair, for theprevention and treatment of dry skin, for the prevention and treatmentof skin wrinkles, for the prevention and treatment of skin spots, forthe prevention and treatment of brittle nails, for the prevention andtreatment of hair loss.

Provided is a method for the maintenance of skin health by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method for the maintenance of hair health by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method for the maintenance of nail health by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method for the prevention and treatment of hair loss byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of brittle nailsby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of skin wrinklesby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of skin spots byadministering to an individual in need thereof a functional foodcomposition as described herein.

This disclosure also relates to the delivery of compounds useful forweight loss using edible or potable substances encapsulated in an ediblemembrane matrix. In particular aspects, the functional food providesfunctionally nutritive benefits for disease prevention and healthwellness through the incorporation of certain biologically activecompounds in the edible substance and/or as particles in the membranematrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, and particles for weightloss. The functional food composition can include a weight loss compoundselected from the group consisting of an appetite suppressant, fatuptake inhibitors, gastrointestinal fillers, and thermogenic compounds.

The functional food composition can include a weight loss compoundselected from the group consisting of thylakoids, thylakoid extracts,and combinations thereof.

The functional food composition can include at least one of the groupconsisting of a vitamin, a mineral, an amino acid, an antioxidant, ananti-inflammatory agent, and an essential fatty acid.

The functional food composition can include at least one of the groupconsisting proteinase inhibitor II, green coffee bean extract,chlorogenic acid, green tea leaf extract, polyphenols, ashwagandhaextract, xanthum gum, and pinolenic acid, hoodia, chitosan, chromiumpicolinate, conjugated linoleic acid, glucomannan, green tea extract,guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin,white bean extract, vitamin D, human chorionic gonadotropin,resveratrol, capsaicin, chia, hoodia, L-carnitine, raspberry ketones,banana leaf, red clover, ginger, almonds, acai berry, flax seeds,leucine, and lipodrene.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The edible particles weight loss and/oradditional edible particles can provide enhanced performance to thematrix.

The functional food composition can comprise edible particles for weightloss and/or additional edible particles can have a size with a volumemean distribution between about 0.1 microns and about 1.0 microns,between about 0.1 microns and about 10.0 microns, between about 0.1microns and about 100.0 microns, between about 0.1 microns and about 1.0millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible unpolymerized matrix, and edible particles for weight loss,combining the edible or potable substance and/or the edibleunpolymerized matrix with the edible particles for weight loss, andencapsulating the edible substance with the edible matrix. The methodcan further comprise the step of polymerizing the edible matrix.

The functional food composition can be used for weight loss management,for the maintenance of a normal healthy body mass index, for thetreatment and prevention of being overweight, and for the treatment andprevention of obesity.

Provided is a method for managing weight by administering to anindividual in need thereof a functional food composition as describedherein. The functional food composition can be administered in an amountsufficient for the maintenance of a normal body mass index. Thefunctional food composition can be administered in an amount sufficientto decrease body mass index.

Provided is a method for the treatment of obese body mass index byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the treatment of overweight body mass index byadministering to an individual in need thereof a functional foodcomposition as described herein.

This disclosure also relates to the delivery of compounds useful forskeletal health using edible or potable substances encapsulated in anedible membrane matrix. In particular aspects, the functional foodprovides functionally nutritive benefits for disease prevention andhealth wellness through the incorporation of certain biologically activecompounds in the edible substance and/or as particles in the membranematrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, and a compound thatpromotes skeletal health. The functional food composition can comprise acompound that promotes (e.g., in the form of edible particles) skeletalhealth selected from the group consisting of a calcium compound, amagnesium compound, vitamin K₂, a calcium uptake enhancer, andderivatives thereof. The calcium uptake enhancer can be selected fromthe group consisting of colecalciferol and ergocalciferol. The calciumuptake enhancer can be vitamin D. The vitamin D concentration can befrom about 1000 to about 4000 IU's, the vitamin K₂ concentration fromabout 50 micrograms to about 500 micrograms, the magnesium concentrationfrom about 40 to about 320 milligrams, and the calcium concentrationfrom about 500-2000 milligrams, in an individual functional foodcomposition serving.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The edible particles for skeletal healthand/or additional edible particles can provide enhanced performance tothe matrix.

The functional food composition edible particles for skeletal healthand/or additional edible particles can have a size with a volume meandistribution between about 0.1 microns and about 1.0 microns, betweenabout 0.1 microns and about 10.0 microns, between about 0.1 microns andabout 100.0 microns, between about 0.1 microns and about 1.0millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible unpolymerized matrix, and a compound that promotes skeletalhealth, combining the edible or potable substance and/or the edibleunpolymerized matrix with the compound that promotes skeletal health,and encapsulating the edible substance with the edible matrix. Themethod can further comprise the step of polymerizing the edible matrix.

The functional food composition can be used for maintenance of skeletalhealth, the prevention of rickets, the prevention of osteoporosis, theprevention of osteomalacia, to increase bone density, and for theprevention and treatment of cardiovascular disease.

Provided is a method for maintaining or improving skeletal health byadministering to an individual in need thereof a functional foodcomposition as described herein. The functional food composition can beadministered in an amount sufficient to increase bone density in anindividual. The functional food composition can be administered in anamount sufficient to decrease chronic joint and skeletal pain.

Provided is a method for the prevention and treatment of a skeletaldisease by administering to an individual in need thereof a functionalfood composition as described herein. The skeletal disease can consistof at least one of rickets, osteoporosis, and osteomalacia.

This disclosure also relates to the delivery of bioflavonoids, carotenesand essential fatty acid compounds using edible or potable substancesencapsulated in an edible membrane matrix. In particular aspects, thefunctional food provides functionally nutritive benefits forcardiovascular disease prevention and health wellness through theincorporation of certain biologically active compounds in the ediblesubstance and/or as particles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, and a cardiovascularhealth compound comprising a bioflavonoid, a carotene, and an essentialfatty acid.

The functional food composition can include a bioflavonoid derived fromat least one of the group consisting of Camellia sinensis, Theobromacacao, varieties thereof, strains thereof, cultivars thereof, andcombinations thereof.

The functional food composition can include bioflavonoid selected fromthe group consisting of esveratrol, quercetin, rutin, catechin,epicatechin, proanthocyanidin, cocoaflavanol, and combinations thereof.

The functional food composition can comprise an essential fatty acidselected from the group consisting of α-linolenic acid, eicosapentanoicacid, docosahexaenoic acid, and combinations thereof.

The functional food composition can comprise carotene selected from thegroup consisting of α-carotene, β-carotene, γ-carotene, δ-carotene,ε-carotene, lycopene, and combinations thereof.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The cardiovascular health compound and/oradditional edible particles can provide enhanced performance to thematrix.

The functional food composition of the cardiovascular health compoundand/or additional edible particles can have a size with a volume meandistribution between about 0.1 microns and about 1.0 microns, betweenabout 0.1 microns and about 10.0 microns, between about 0.1 microns andabout 100.0 microns, between about 0.1 microns and about 1.0millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible matrix, and a cardiovascular health compound comprising abioflavonoid, a carotene, and an essential fatty acid, combining theedible or potable substance and/or the edible matrix with thecardiovascular health compound, and encapsulating the edible substancewith the edible matrix. The method can further comprise the step ofpolymerizing the edible matrix.

The functional food composition can be used for the maintenance ofcardiovascular health, for treatment of cardiovascular disease, fortreatment of high blood pressure, and for treatment of high bloodcholesterol.

Provided is a method for the maintenance of cardiovascular health byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the treatment of cardiovascular disease byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the treatment of high blood pressure byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the treatment of high blood cholesterol byadministering to an individual in need thereof a functional foodcomposition as described herein.

This disclosure also relates to the delivery of compounds useful forjoint and cartilage health using edible or potable substancesencapsulated in an edible membrane matrix. In particular aspects, thefunctional food provides functionally nutritive benefits for diseaseprevention and health wellness through the incorporation of certainbiologically active compounds in the edible substance and/or asparticles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, and particles for jointand cartilage health. The joint and cartilage health compound may beglucosamine, chondroitin, collagen, hyaluronic acid, salts thereof,complexes thereof, bioavailable derivatives thereof, and bioactivederivatives thereof.

The functional food composition can consist of about 500 milligrams toabout 2000 milligrams chondroitin, about 500 milligrams to about 2000milligrams of glucosamine, about 20 to about 200 milligrams hyaluronicacid, or about 500 milligrams to about 3000 milligrams of collagen.

The functional food composition can include at least one ingredientselected from the group consisting of a vitamin, a mineral, an aminoacid, an antioxidant, an anti-inflammatory agent, and an essential fattyacid.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The edible particles for joint and cartilagehealth and/or additional edible particles can provide enhancedperformance to the matrix.

The functional food composition can comprise edible particles for jointand cartilage health and/or additional edible particles can have a sizewith a volume mean distribution between about 0.1 microns and about 1.0microns, between about 0.1 microns and about 10.0 microns, between about0.1 microns and about 100.0 microns, between about 0.1 microns and about1.0 millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible unpolymerized matrix, and edible particles for joint andcartilage health, combining the edible or potable substance and/or theedible unpolymerized matrix with the edible particles for joint andcartilage health, and encapsulating the edible substance with the ediblematrix. The method can further comprise the step of polymerizing theedible matrix.

The functional food composition can be used for maintenance of joint andcartilage health, the treatment and prevention of arthritis, thetreatment and prevention of osteoarthritis, the treatment and preventionof rheumatoid arthritis, the treatment and prevention of psoriaticarthritis, the treatment and prevention of joint effusion, the treatmentand prevention of joint pain, the treatment and prevention of jointinflammation, the treatment and prevention of synovitis, and forpost-operative care.

Provided is a method for maintaining or improving joint and cartilagehealth by administering to an individual in need thereof a functionalfood composition as described herein. The functional food compositioncan be administered in an amount sufficient to decrease chronic jointpain in an individual.

Provided is a method for the prevention and treatment of a degenerativejoint disease by administering to an individual in need thereof afunctional food composition as described herein. The degenerative jointdisease can consist of at least one of the group consisting ofarthritis, joint effusion, and deterioration of proper joint function,and the arthritis can consist of at least one of the group selected fromosteoarthritis, rheumatoid arthritis, and psoriatic arthritis.

Provided is a method for the prevention and treatment of a jointdisorder by administering to an individual in need thereof a functionalfood composition as described herein. The joint disorder can consist ofat least one of the group selected from joint inflammation, chronicjoint pain, and synovitis.

This disclosure also relates to the delivery of multivitamin compoundsusing edible or potable substances encapsulated in an edible membranematrix. In particular aspects, the functional food provides functionallynutritive benefits for disease prevention and health wellness throughthe incorporation of certain biologically active compounds in the ediblesubstance and/or as particles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, and a multivitamincompound. The functional food composition can include a multivitaminwherein the multivitamin compound is at least two of the groupconsisting of vitamin A, vitamin B₁, vitamin B₂, vitamin B₃, vitamin B₅,vitamin B₆, vitamin B₉, vitamin B₁₂, vitamin C, vitamin D₃, vitamin E,vitamin K₁, vitamin K₂, vitamin H (biotin), and combinations thereof.

The functional food composition can be a multivitamin compound furthercomprising minerals. The functional food composition mineral can be atleast one of the group selected from boron, calcium, chloride, chromium,cobalt, copper, fluorine, iodine, iron, magnesium, manganese,molybdenum, nickel, phosphorous, potassium, selenium, silicon, sodium,strontium, sulfur, vanadium, zinc, and combinations thereof.

The functional food composition can further comprise at least one of thegroup consisting of an amino acid, an antioxidant, a carotenoid, aflavonoid, an isoflavone, a nutraceutical, and combinations thereof.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The multivitamin compound and/or additionaledible particles can provide enhanced performance to the matrix.

The functional food composition edible multivitamin compound and/oradditional edible particles can have a size with a volume meandistribution between about 0.1 microns and about 1.0 microns, betweenabout 0.1 microns and about 10.0 microns, between about 0.1 microns andabout 100.0 microns, between about 0.1 microns and about 1.0millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible matrix, and a multivitamin compound, combining the edible orpotable substance and/or the edible matrix with the multivitamincompound, and encapsulating the edible substance with the edible matrix.The method can further comprise the step of polymerizing the ediblematrix.

The functional food composition can be used for maintenance ofrecommended daily allowance of vitamins and minerals, for the treatmentof vitamin and mineral deficiency related to dietary imbalance, for thetreatment of vitamin and mineral deficiency related to chronic disease,for the treatment of vitamin and mineral deficiency related to thetreatment of a chronic disease, for the treatment of vitamin and mineraldeficiency related to a weight loss diet.

Provided is a method for the treatment of vitamin and mineral deficiencyby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the maintenance of recommended daily allowancesof vitamins and minerals by administering to an individual in needthereof a functional food composition as described herein.

This disclosure also relates to the delivery of essential fatty acidcompounds using edible or potable substances encapsulated in an ediblemembrane matrix. In particular aspects, the functional food providesfunctionally nutritive benefits for disease prevention and healthwellness through the incorporation of certain biologically activecompounds in the edible substance and/or as particles in the membranematrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, and an essential fattyacid compound. The functional food composition can include an essentialfatty acid compound that is an essential fatty acid. The functional foodcomposition essential fatty acid can be selected from the groupconsisting of α-linolenic acid, eicosapentanoic acid, docosahexaenoicacid, and combinations thereof.

The functional food composition can further comprise dietary fiber. Thedietary fiber can be selected from the group consisting ofgalacto-oligosaccharides, inulin and oligofructose(fructo-oligosaccharide), isomalto-oligosaccharides, lactulose,lactosucrose, transgalacto-oligosaccharides, soybean oligosaccharides,tagatose, xylo-oligosaccharides, and combinations thereof.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The essential fatty acid compound, dietaryfiber, and/or additional edible particles can provide enhancedperformance to the matrix.

The functional food composition essential fatty acids, dietary fiber,and/or additional edible particles can have a size with a volume meandistribution between about 0.1 microns and about 1.0 microns, betweenabout 0.1 microns and about 10.0 microns, between about 0.1 microns andabout 100.0 microns, between about 0.1 microns and about 1.0millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible unpolymerized matrix, and an essential fatty acid compound,combining the edible or potable substance and/or the edibleunpolymerized matrix with the essential fatty acid compound, andencapsulating the edible substance with the edible matrix. The methodcan further comprise the step of polymerizing the edible matrix.

The functional food composition can be used for promoting normaldevelopment of the brain, eyes and nerves, for maintenance of normaldevelopment of the brain, eyes and nerves, for maintenance of brain, eyeand nerve health, for the prevention and treatment of coronary disease,for the prevention and treatment of dementia, for the prevention andtreatment of depression, and for the prevention and treatment ofarthritis.

Provided is a method for promoting normal development and healthmaintenance of the brain, eyes and nerves by administering to anindividual in need thereof a functional food composition as describedherein.

Provided is a method for the treatment of coronary disease byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the maintenance of coronary health byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided herein is a method for the prevention and treatment of dementiaby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of depression byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of arthritis byadministering to an individual in need thereof a functional foodcomposition as described herein.

This disclosure also relates to the delivery of branched chain aminoacids using edible or potable substances encapsulated in an ediblemembrane matrix. In particular aspects, the functional food providesfunctionally nutritive benefits for consumers by contributing to thetreatment and prevention of certain diseases and disorders and themaintenance of general health and wellness through the incorporation ofcertain biologically active compounds in the edible substance and/or asparticles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, the cross-linked matrixcomprising an edible polymer, and a branched chain amino acid.

The functional food composition can further comprise L-glutamine. Thefunctional food composition branched chain amino acid can be selectedfrom the group consisting of L-leucine, L-isoleucine, L-valine, andcombinations thereof.

The functional food composition can further comprise a multivitamincomposition.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The branched chain amino acid, L-glutamine,and/or additional edible particles can provide enhanced performance tothe matrix.

The functional food composition of the branched chain amino acid,L-glutamine, and/or additional edible particles can have a size with avolume mean distribution between about 0.1 microns and about 1.0microns, between about 0.1 microns and about 10.0 microns, between about0.1 microns and about 100.0 microns, between about 0.1 microns and about1.0 millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible matrix, and a branched chain amino acid, combining the edible orpotable substance and/or the edible matrix with the branched chain aminoacid, and encapsulating the edible substance with the edible matrix. Themethod can further comprise the step of polymerizing the edible matrix.

The functional food composition can be used for the maintenance ofmuscle mass, to increase muscle mass, for the prevention and treatmentof muscle mass loss during post-operative care, for the prevention andtreatment of muscle mass loss during trauma care, for the prevention andtreatment of muscle mass loss from malignant disease, and for theprevention and treatment of muscle mass loss from burn care.

Provided is method for the maintenance of muscle mass by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method to increase muscle mass by administering to anindividual in need thereof a functional food composition as describedherein.

Provided is a method for the prevention and treatment of muscle massloss during post-operative care by administering to an individual inneed thereof a functional food composition as described herein.

Provided is a method for the prevention and treatment of muscle massloss during trauma care by administering to an individual in needthereof a functional food composition as described herein.

Provided is a method for the prevention and treatment of muscle massloss from malignant disease by administering to an individual in needthereof a functional food composition as described herein.

Provided is a method for the prevention and treatment of muscle massloss from burn care by administering to an individual in need thereof afunctional food composition as described herein.

This disclosure also relates to the delivery of antioxidants usingedible or potable substances encapsulated in an edible membrane matrix.In particular aspects, the functional food provides functionallynutritive benefits for consumers by contributing to the treatment andprevention of certain diseases and disorders and the maintenance ofgeneral health and wellness through the incorporation of certainbiologically active compounds in the edible substance and/or asparticles in the membrane matrix.

Provided herein is a functional food composition and method for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, the cross-linked matrixcomprising an edible polymer and an edible antioxidant containingcompound characterized by oxygen radical absorbance capacity above about1000 per 100 grams.

The functional food composition can include edible particles for atleast one of the group consisting of a bioflavonoid, a carotene, avitamin, and combinations thereof, wherein the bioflavonoid is selectedfrom the group consisting of esveratrol, quercetin, rutin, catechin,epicatechin, proanthocyanidin, and combinations thereof, wherein thecarotene is selected from the group consisting of α-carotene,β-carotene, γ-carotene, δ-carotene, ε-carotene, lycopene, andcombinations thereof, and wherein the vitamin is selected from the groupconsisting of vitamin A, vitamin C, vitamin E, and combinations thereof.

The functional food composition can further comprise a dietary fiber.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The edible antioxidant containing compoundcompound and/or additional edible particles can provide enhancedperformance to the matrix.

The functional food composition cross-linked matrix can have a thicknessfrom about 10 microns to about 200 millimeters.

The functional food composition of the edible antioxidant containingcompound and/or additional edible particles can have a size with avolume mean distribution between about 0.1 microns and about 1.0microns, between about 0.1 microns and about 10.0 microns, between about0.1 microns and about 100.0 microns, between about 0.1 microns and about1.0 millimeters, or between about 0.1 and about 3 millimeters.

Provided herein is a method of preparing a functional food composition,comprising the steps of providing an edible or potable substance, anedible unpolymerized matrix, and particles of an edible antioxidantcompound, wherein the edible antioxidant containing compound ischaracterized by an oxygen radical absorbance capacity above about 1000per 100 grams, combining the edible or potable substance and/or theedible unpolymerized matrix with the edible antioxidant containingcompound, and encapsulating the edible substance with the edible matrix.The method can further comprise the step of polymerizing the ediblematrix.

The functional food composition can be used for the maintenance of skinhealth, for the maintenance of nails, for the maintenance of hair, forthe prevention and treatment of dry skin, for the prevention andtreatment of skin wrinkles, for the prevention and treatment of skinspots, for the prevention and treatment of brittle nails, for theprevention and treatment of hair loss, for the maintenance ofcardiovascular health, for the treatment of cardiovascular disease, forthe maintenance of brain function and mental acuity, for the maintenanceof vision health, for the maintenance of healthy blood sugar levels, andfor the maintenance of urinary tract health.

Provided is a method for the maintenance of cardiovascular health byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the treatment of cardiovascular disease byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the maintenance of skin health by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method for the maintenance of hair health by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method for the maintenance of nail health by administeringto an individual in need thereof a functional food composition asdescribed herein.

Provided is a method for the prevention and treatment of hair loss byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of brittle nailsby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of skin wrinklesby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of skin spots byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the prevention and treatment of high bloodcholesterol by administering to an individual in need thereof afunctional food composition as described herein.

Provided is a method for the maintenance of brain function and mentalacuity by administering to an individual in need thereof a functionalfood composition as described herein.

Provided is a method for the maintenance of vision health byadministering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the maintenance of healthy blood sugar levelsby administering to an individual in need thereof a functional foodcomposition as described herein.

Provided is a method for the maintenance of urinary tract health byadministering to an individual in need thereof a functional foodcomposition as described herein.

This disclosure also relates to functional food compositions. Functionalfood compositions are designed to deliver sufficient quantities andquality of β-glucans and probiotics using edible or potable substancesencapsulated in an edible membrane matrix. In particular aspects, thefunctional food composition provides nutritive and health benefits forimmunological response, disease treatment and prevention, and healthmaintenance through the incorporation of certain biologically activecompounds in the edible substance and/or as particles in the membranematrix.

Provided herein is a functional food composition and methods for making,comprising an edible or potable substance, a cross-linked matrixencapsulating the edible or potable substance, a probiotic, andβ-glucan. The matrix can comprise the β-glucan and the edible or potablesubstance component comprises the probiotic, or the matrix comprises theprobiotic and the edible or potable substance comprises the β-glucan.The matrix can comprise the probiotic and the β-glucan, or the edible orpotable substance can comprise the probiotic and the β-glucan.

The functional food composition can comprise a probiotic concentrationfrom about 1.0 to about 100 billion colony forming units in anindividual edible transport vessel, and the probiotic can be an organismselected from the genera group consisting of Aspergillus, Bacillus,Bacteroides, Bifidobacterium, Brettanomyces, Enterococcum,Kluyveromyces, Lactobacillus, Lactococcus, Leuconostoc, Pediococcus,Propionibacterium, Saccharomyces, Shewanella, Streptococcus,Torulaspora, Vagococcus, and any derivatives, strains, and combinationsthereof.

The functional food composition can comprise a probiotic that is heatkilled. The heat killed probiotic can be in the functional food inamounts of about 100 mg to about 500 mg.

The functional food composition can comprise a β-glucan where theβ-glucan is (1,3)-(1,6)-β-glucan. The β-glucan can be (1,3)-β-glycosidiclinked D-glucose subunits β-(1,6)-linked to (1,3)-β-glycosidic linkedD-glucose side chains of varying length and bonded to the backbonesubunits at irregular or regular intervals. The β-glucan concentrationcan be from about 1.0 milligrams to 5.0 grams.

The functional food composition can comprise additional edible particlesin the cross-linked matrix. The β-glucan, the probiotic, and/oradditional edible particles can provide enhanced performance to thematrix.

The β-glucan, the probiotic, and/or additional edible particles cancomprise a size having a volume mean distribution between about 0.1microns and about 1.0 microns, between about 0.1 microns and about 10.0microns, between about 0.1 microns and about 100.0 microns, betweenabout 0.1 microns and about 1.0 millimeters, or between about 0.1 andabout 3 millimeters.

The functional food composition can be used for increasing beneficialimmune responses, for decreasing adverse immune responses, formaintaining healthy immune responses, for enhancement of a vaccinationresponse, to stimulate antibody production, to reduce the occurrence ofsymptomatic common cold infections, for treating fungal infections, fortreating Candida albicans infections, for a free-radical scavenger, fortreatment of cancer, and for protection against radiation exposure.

Provided is a method for maintaining or improving immune health byadministering to an individual in need thereof a functional foodcomposition as described herein. The functional food composition can beadministered in an amount sufficient to stimulate antibody production,for enhancement of a vaccination response, to reduce the occurrence ofsymptomatic common cold infections, for treating fungal infections, fortreating Candida albicans infections, for use as a free-radicalscavenger, for treatment of cancer, for protection against radiation.

In all functional food compositions, the matrix can be comprised of anedible polymer charge cross-linked by multivalent ions, includingcross-linking interactions between the edible particles and ediblepolymer or plurality of edible polymers via bridges formed by themultivalent ions. The matrix can comprise a polysaccharide selected fromthe group consisting of a hydrocolloid, shellac, and fibers.

The cross-linked matrix of the functional food composition can have athickness from about 10 microns to about 200 millimeters.

The functional food composition can have an edible or potable substancecomprising at least one of a powder, a gel, an emulsion, a foam, asolid, and combinations thereof. The edible or potable substance can beselected from the group consisting of fruit, vegetable, meat, a dairyproduct, a carbohydrate food product, a botanical, a confection, andcombinations thereof.

The functional food composition can have an edible or potable substancecomprising a liquid, particularly wherein the liquid comprises at leastone of water, an alcohol, a juice, an alcohol mixed drink, a coffeeproduct, a tea product, a soft drink, an energy supplement product, adietary supplement, a confection, fortified substances thereof, andcombinations thereof.

The functional food composition can have an edible or potable substancedefining a volume of between about 5 and 1,250 cubic centimeters, andthe cross-linked matrix has a strength sufficient to contain andtransport a liquid water volume equivalent to the interior volumedefined by the edible or potable substance.

DESCRIPTION OF DRAWINGS

FIG. 1 shows the chemical structure of an alginate polymer-(M)_(m)-(G)_(n)- (M: mannuronate; G: guluronate).

FIG. 2 illustrates polymerization of sodium alginates via divalentcations (e.g., Ca²⁺).

FIG. 3 is a schematic illustrating bonding between positive particles(e.g., Ca⁺ or Mg²⁺) and negative particles (e.g., alginate or foodparticles).

FIG. 4 illustrates multiple transport systems arranged in shells.

FIG. 5 illustrates a transport system having large particles suspendedin an outer membrane layer.

FIG. 6 illustrates a transport system having small particles suspendedin an outer membrane layer.

FIG. 7 illustrates a transport system having both large and smallparticles suspended in an outer membrane layer.

FIG. 8 illustrates a transport system having an outer membrane layerthat is non-uniformly shaped.

FIGS. 9A-9C illustrate a multimembrane composition with particlesembedded in the membrane and a particulate layer between membranes.

DETAILED DESCRIPTION Definitions

B-glucan refers generally to chains of D-glucose polysaccharides linkedby beta-type glycosidic bonds.

(β-1,3):(β-1,6) D-glucan and (1,3)-(1,6)-β-glucan refer to glucosepolysaccharides consisting of a backbone of (1,3)-β-glycosidic linkedD-glucose subunits β-(1,6)-linked to (1,3)-β-glycosidic linked D-glucoseside chains of varying length and bonded to the backbone subunits atirregular or regular intervals.

“Bioavailable” and “bioavailability” refer to the quantity, fraction orproportion of the administered or ingested substance capable of beingabsorbed and available for use or storage, and varies according tophysiological state and nutritional status of a consumer.

“Bioflavonoid” refers to flavones, isoflavanoids and neoflavanoids,sub-classes, sub-groups, and chemically related compounds thereof,including flavanols such as catechins and epicatechins, as used anddefined according to IUPAC nomenclature and designation.

“Biologically active compound” and “biologically active agent” refer toany compound that elicits a response in or from a biological systemand/or organism.

“Body Mass Index” refers to a measure of body fat based on height andweight that applies to adult men and women, wherein the quantitativemeasure is used to categorize an adult's weight as underweight, normalweight, overweight, and obese.

“Branched chain amino acid” refers to the essential amino acidsL-leucine, L-isoleucine, and L-valine, separately or in combination.

“Elastic tissue component” refers to protein compounds derived from orlocated in skin, bone, connective tissue such as cartilage, tendons andligaments, and/or other fibrous tissues as found in vertebrates,including, without limitation, collagen and elastin, that arecharacterized by increased tensile strength and/or elasticity.

“Essential fatty acid” refers to omega-3 fatty acids that cannot besynthesized de novo by the human body, and includes α-linoleic acid(ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Itis known that diets including the shorter-chained omega-3 fatty acidALA, will allow for the human body to form long-chain omega-3 fatty acidEPA and then from EPA, the most crucial, DHA, but this process has lowefficiency.

“Fortified” or “fortify” refers to the adding of ingredients tosomething or to add further ingredients to food or drink in order toimprove its flavor or add nutrients.

“Functional food” refers to an edible composition fortified with knownbiologically active compounds or agents that provide enhanced benefit(e.g. a health benefit, nutritional benefit) to the consumer. Theenhanced benefit can be quantitative, qualitative or subjective andinclude for example, health promotion and disease prevention. Ingeneral, the functional food is fortified with defined (qualitative orquantitative) amounts of the known beneficial ingredients to provide thedesired benefit.

“Integument” refers to skin and protein based skin cell productsthereof, including hair and finger/toe nails.

“Matrix” refers to the molecular three dimensional architecture of apolymerized or unpolymerized polymer or copolymeric substance.

“Matrices” refers to two or more of a distinct matrix.

“Membrane” as used herein refers to the polymerized polymers and/orco-polymers encapsulating an edible or potable substance.

“Microbiota” refers to the collective term for microflora (i.e., anytype of minute organism) that may be found within a given environment.

“Microflora” refers to living microscopic microorganisms that maintain amore or less constant presence in a particular area of living biologicalsystem, and includes bacteria, viruses, protozoa, yeasts and fungi.

“Nutraceutical” refers to a product isolated or purified, often fromfoods, that is generally sold in medicinal forms not usually associatedwith food, includes dietary supplements and food-related products forpromoting health.

“ORAC” refers to a method of determining oxygen radical absorbancecapacity. Data from the ORAC method shows antioxidant capacity ofbiologically active compounds in vitro.

“Probiotic” refers to living microorganisms that, on ingestion by a hostorganism, and in sufficient concentration, exert health benefits to thehost organism beyond basic nutrition.

“Prebiotic” refers to a selectively fermented ingredient that allowsspecific changes, both in the composition and/or activity in thegastrointestinal microbiota that confers benefits upon host well-beingand health.

“Shells” refers to relatively unpliable to hard polymerized polymers orco-polymers.

“Skins” as used herein refers to the polymerized polymers and/orco-polymers encapsulating an edible or potable substance.

I. Overview of the Prebiotic/Probiotic Functional Food Composition

The disclosure relates to functional food compositions that contain aprebiotic and a probiotic when, upon ingestion, promote gastrointestinalhealth and well-being. The functional food composition contains anedible or potable substance that is encapsulated in an edible membrane,and further contains a probiotic and a prebiotic. The functional foodcompositions described herein provide a convenient and improved way forindividuals to consume probiotics in quantities needed to promotegastrointestinal health and well-being.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits include providing an importantnutritive food source, vitamins and supplements, or probiotics, whichcontributes to the prevention, management and treatment of chronicdiseases or disorders. This health improvement benefit can also beprovided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood product is gained. However, delivery systems for some bioavailablecompounds including prebiotics and probiotics often reduce theirviability, resulting in suboptimal quantities of these compounds beingmade available to the consumer.

The functional food compositions described herein provide for asignificant improvement in the viability and concentration of probioticsavailable to a consumer. Within these compositions, the prebioticcompounds and probiotic compounds are compartmentalized so that theedible or potable substance and the encapsulating membrane do not bothcontain the probiotic or both contain the prebiotic. Upon masticationand ingestion, the probiotic and the prebiotic are released from thefunctional food composition, and combined in the intestinal tractwherein the prebiotic provides an immediately available nutrition sourcefor the probiotic to grow. Prebiotics and probiotics can thus beengineered and matched to each other to provide an optimal condition forquick population in the gut upon consumption by a host.

The functional food compositions described herein are designed toprovide prebiotics and probiotics in biologically effective quantitiessuperior to commonly used products. The compositions are particularlywell-suited for providing a larger active ingredient load as well asbeing amenable for controlling the actual portion size for an intendedhealth benefit. An eight ounce serving of commercial yogurt in plasticcontainers commonly provides a microbial load of less than 1 billioncolony forming units (BCFU), far below a bacterial load level sufficientto provide health benefits. The compositions described herein can bedesigned to provide up to 100 BCFU's.

These functional food compositions also enhance the stability, gustatoryexperience, and delivery of functional biologically active compounds.Functional food compositions contain and protect ingestible/ediblesubstances, such as ice cream, yogurts, etc. and probiotics orprebiotics, by encapsulating the substance within edible orbiodegradable membranes. The edible membranes of these compositions canbe formed from various natural polymeric substances allowing differentcompositions to be easily transported and consumed.

Considerations for the choice of probiotic or probiotic combinations foruse in the function food compositions are that the probiotic remainviable until ingestion in a biologically effective concentration, andthe probiotic be able to confer a health benefit to and/or use fortreatment of a gastro-intestinal, immune or other systemic disorder inthe host organism. In all instances, it is desirable that these foodcompositions (product)) include effectual probiotics to re-establishhealthy intestinal bacterial flora or otherwise confer a health benefitto a host organism ingesting the probiotic.

Important variables when specifically considering a prebiotic and aprobiotic for use in the functional food composition include: 1) theinteraction between the prebiotic and probiotic, 2) the by-product leftby the probiotic, 3) the taste and/or texture of the edible compositionafter the prebiotic and probiotic interact, 4) the rate of replicationof the probiotic, and 5) the health benefit(s) the probiotic and/orprebiotic may convey.

In general, the prebiotic and the probiotic are substantially separatedfrom each other so that the matrix component and the edible or potablesubstance component contain the prebiotic or the probiotic. If thematrix component includes the prebiotic, the edible or potable substancecomponent can include the probiotic. If the matrix component includesthe probiotic, the edible or potable substance component can include theprebiotic. In some applications, the location of the prebiotic and theprobiotic may be conditionally dependent on each other. Theeffectiveness of the prebiotic or probiotic may be optimized based onplacement within either the matrix or the edible or potable compositionor they may be equally as effective in either location.

In general, the prebiotic and probiotic are separated in the compositionso there is no interaction between the two compounds, and are designedto be released from the food product after or upon consumption. Afterconsuming the serving of functional food composition, the prebiotic maybe broken down by the body's natural microflora which could provide abetter suited environment for the additional probiotics delivered by theedible product. The prebiotic and probiotic may interact after theedible composition is broken down and before the edible compositionreaches the gastrointestinal tract (e.g., chewing, etc.). Masticationand ingestion release the components from the membrane matrix and theedible or potable substance to allow them mix, interact to allow forgrowth, and to colonize in the gut in sufficient amounts.

If desired, the functional food compositions can be prepared so that theprebiotic and probiotic are allowed to interact within the food productby diffusion from the membrane to the encapsulated food or vice versa.In these instances, the physical and/or chemical characteristics of themembrane can change as the prebiotic is used by the probiotic. As theprebiotic is used by the probiotic over time, the membrane can bealtered in terms of its physical and/or chemical characteristics, forexample, permeability, elasticity, color, taste, tensile strength,texture, pH, overall charge, etc. The changes occurring with the ediblecomposition can be an indicator (e.g., the matrix displays a noticeablecolor change to indicate a sufficient number of probiotics has beenreached, etc.). In some embodiments, the consumption of the prebiotic bythe probiotic leaves behind by-products that affect the mouth feel oruser experience of the edible composition (e.g., carbonation, etc.). Insome embodiments, the by-products left in the edible product by theprobiotic confer separate health benefits and/or alter the physicaland/or chemical characteristics of the edible composition.

In some applications, the matrix pre- or probiotic component may diffuseinto the edible or potable product while the edible or potable substancepre- or probiotic component remains in the edible or potable substance.Similarly, the edible or potable substance pre- or probiotic componentcan diffuse into the matrix while the matrix pre- or probiotic componentremains in the matrix. After diffusion, the matrix pre- or probioticcomponent and the edible or potable substance pre- or probioticcomponent may interact. The edible matrix also can affect the diffusionrate between the probiotic microorganism and the prebiotic nutrientsource for the microorganism based on type of material, charge, subunitcomposition, and/or embedded particles. If the probiotic diffuses out ofthe membrane, it may implement its valuable properties on thesurrounding environment (e.g., the digestive tract, etc.). The matrixcan be selectively permeable for prebiotic and/or probiotic diffusionwhile the edible product remains encapsulated and substances outside ofthe embodiment are repelled.

It may be desirable that the prebiotic and probiotic remain in theirrespective locations within the edible composition, but the probioticmay access the embedded prebiotic at the matrix-edible or potablesubstance interface and the probiotic may flourish within its respectivelocation. The probiotic may use the prebiotic entirely, partially, ornot at all while embodied within the same edible composition. If theprebiotic is in the edible composition in excess for the probiotic, theprebiotic may act as nutritional support for both the probiotic and theconsumer.

Health benefit aspects contemplated for use of the pre- and probioticfunctional food compositions described herein include relief fromintestinal inflammation, pathogen related diarrhea, antibiotic relateddiarrhea, various irritable bowel syndromes, urogenital infections,allergies, lactose intolerance, colon cancer, high cholesterol, highblood pressure, immunity function, immune based infections, pepticulcers, inflammation, colitis, necrotizing enterocolitis, Crohn'sDisease, eczema, Inflammatory Bowel Disease, vitamin production, etc.Health and wellness preventative treatment with probiotics includesdecreased intestinal gas and bloating, increased fecal transit time,relief from constipation, improved digestion, increased flora count instool, etc. For example, probiotics may beneficially affect the host byaugmenting the host intestinal microbial population beyond the amountalready existing, thus possibly inhibiting unhealthy or harmfulpathogens. Furthermore, improvement of these and other gastrointestinaldisorders may raise the overall quality of life and daily functionalcapacity by increasing the regularity of bowel movements and easing painrelated to certain disorders.

In general, prebiotics are included in the membrane and/or the edible orpotable substance to further promote probiotic activity. The threecriteria used for prebiotic classification are resistance to digestion,fermentation availability by intestinal microflora, and the selectivestimulation of the growth and/or activity of intestinal bacteriaassociated with health and wellbeing. The prebiotics described hereinare fortified within the functional food composition, in concentrationand/or type, to be in addition to natural levels of a prebiotic in thefood source.

As described in more detail herein, the common probiotics include lacticacid bacteria, bifidobacteria, yeasts and bacilli, and are oftenconsumed as part of a fermented food source, (e.g., yogurt, soy yogurt,etc.) with added live microbiological cultures.

Measurable outcomes for general health maintenance can be determinedquantitatively and/or qualitatively by monitoring, for example, apatient's or consumer's change in composition of intestinal microflora,possibly feelings of well-being, and bowel regularity after a program orregimen of daily consumption of the functional food composition isestablished. For pretreatment/prevention of diseases, conditions and/orsyndroms, the consumer or patient may show milder symptoms or nosymptoms. In acute conditions for which the consumer or patient is usingthe functional food composition, for example diarrheal conditions (i.e.traveler's, antibiotic or viral), the outcome would be faster resolutionand reduction in severity for treatment. Chronic conditions such asirritable bowel syndrome, inflammatory bowel disease, Crohn's Disease,etc., a patient or consumer would show measurable reduction in number ofepisodes and severity of diarrhea and or constipation. In general, areduction in abdominal pain and discomfort, improvement in quality oflife and ability to perform activities of daily living, measurabledifferences in frequency of episodic conditions and evaluation ofchanges in concentration of gastrointestinal microflora are allindicators of the health benefits when consuming the functional foodcompositions for gastrointestinal health described herein.

Prebiotic and Probiotic Compositions

Common probiotics include lactic acid bacteria, bifidobacteria, yeastsand bacilli, and are often consumed as part of a fermented food source,(e.g., yogurt, soy yogurt, etc.) with added live microbiologicalcultures. Probiotics in concentration and/or type contained within thefunctional food compositions included herein may be used in addition tonatural levels of probiotics in the food source.

Probiotics for use in the foods described herein include, but are notlimited to, Aspergillus niger, Aspergillus oryzae, Bacillus coagulans,Bacillus lentus, Bacillus licheniformis, Bacillus pumilus, Bacillussubtilis, Bacteroides amylophilus, Bacteroides capillosus, Bacteroidesruminocola, Bacteroides suis, Bifidobacterium animalis, Bifidobacteriumbifidum, Bifidobacterium breve, Bifidobacterium infantis,Bifidobacterium licheniformis, Bifidobacterium longum, Bifidobacteriumpseudo longum, Bifidobacterium subtilus, Bifidobacterium thermophilum,Enterococcus cremoris, Enterococcus diacetylactis, Enterococcus faecium,Enterococcus thermophilus, Lactobacillus acidophilus, Lactobacillusamylovorus, Lactobacillus ansporogenes, Lactobacillus brevis,Lactobacillus buchneri, Lactobacillus bulgaris, Lactobacillus casei,Lactobacillus caucasicus, Lactobacillus cellobiosus, Lactobacilluscrispatus, Lactobacillus curvatus, Lactobacillus delbrueckii,Lactobacillus farciminis, Lactobacillus fermentum, Lactobacillusgallinarum, Lactobacillus gasseri, Lactobacillus GG, Lactobacillushelveticus, Lactobacillus johnsonii, Lactobacillus kefir, Lactobacilluslactis, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillusrhamnosus (casei), Lactobacillus salivarius, Lactococcus lactis,Leuconostoc mesenteroides, Pediococcus acidilactici, Pediococcusacidilacticii, Pediococcus cerevisiae, Pediococcus pentosaceus,Propionbacterium freudenreichii, Propionibacterium shermanii,Saccharomyces boulardii, Saccharomyces cerevisiae, Shewanellacolwelliana, Shewanella olleyana, Shewanella putrefaciens, Streptococcuscremoris, Streptococcus faecium, Streptococcus infantis, Streptococcusthermophilus, Vagococcus fluvialis, Bacillus coagulans GBI-30, 6086,Bifidobacterium animalis DN 173 010, Bifidobacterium animalis subsp.lactis BB-12, Bifidobacterium breve Yakult, Bifidobacterium infantis35624, Bifidobacterium lactis HN019 (DR10), Bifidobacterium longumBB536, Bifidobacterium longum subsp. infantis 35624, Enterococcus LAB SF68, Escerichia coli Nissle 1917, Lactobacillus acidophilus NCFM,Lactobacillus acidophilus LA-5, Lactobacillus acidophilus NCFM,Lactobacillus casei subspecies casei, Lactobacillus casei DN-114 001,Lactobacillus casei CRL431, Lactobacillus casei F19, Lactobacillus caseiShirota, Lactobacillus delbrueckii subspecies bulgaricus, Lactobacillusdelbrueckii subspecies lactis, Lactobacillus paracasei St11 (orNCC2461), Lactobacillus johnsonii La1 (Lj1), Lactobacillus johnsoniiNCC533, Lactobacillus plantarum 299v, Lactobacillus rhamnosus ATCC 53013(LG), Lactobacillus rhamnosus LB21, Lactobacillus reuteri ATCC 55730,Lactobacillus salivarius (UCC118), Lactobacillus reuteri SD2112,Lactococcus lactis L1A, Lactococcus lactis subspecies lactis,Lactococcus lactis subspecies lactis biovariant diacetylactis,Lactococcus lactis subspecies cremoris, Leuconostoc mesenteroidessubspecies cremoris, Leuconostoc mesenteroides subspecies dextranicum,Lactobacillus reuteri Protectis (DSM 17938, daughter strain of ATCC55730), Saccharomyces cerevisiae boulardii, Saccharomyces cerevisiaeboulardii (lyo), Lactobacillus bulgaricus, Streptococcus thermophiles,Bifidobacterium spp, and any other strains, derivatives, andcombinations thereof, including, but not limited to, Lactobacillusrhamnosus GR-1 & Lactobacillus reuteri RC-14, Lactobacillus acidophilusCL 1285 & Lactobacillus casei Lbc80r, Lactobacillus rhamnosus (ATTSD5675) & Lactobacillus acidophilus (STCC SD5221), VSL #3 (a combinationof 1 strain of Streptococcus thermophiles, four strains of Lactobacillusspecies, & three Bifidobacterium species strains from Sigma-TauPharmaceuticals), Lactobacillus acidophilus NCFM & Bifidobacteriumbifidum BB-12, Lactobacillus acidophilus CUL60 & Bifidobacterium bifidumCUL20, Lactobacillus acidophilus CL1285 & Lactobacillus casei LBC8OR,Lactobacillus helveticus R0052 & Lactobacillus rhamnosus R0011, Bacillusclausii (strains O/C, NR, SIN and T), Lactobacillus plantarum HEAL 9 &Lactobacillus paracasei 8700:2, other genetic variants thereof, andcombinations and other combinations thereof.

When the dosage or intake of the effective dose of the activeingredients of the functional food composition are indicated by thenumber (concentration) of the probiotic, it is preferable that theintake is about 0.5-1.0 (BCFU) or more per day, more preferably about 10BCFU's or more per day, more preferably about 50 BCFU's or more per day,more preferably about 100 BCFU's or more per day. The concentration ofprobiotic to be contained in an individual product serving is determinedaccording to the amount of servings ingested per day. The concentrationof probiotic present in the functional food composition can be less thanabout 1 BCFU's, about 1 to about 2 BCFU's, about 3 to about 5 BCFU's,about 5 to about 10 BCFU's, about 10 to about 20 BCFU's, about 20 toabout 30 BCFU's, about 30 to about 40 BCFU's, about 40 to about 50BCFU's, about 50 to about 60 BCFU's, about 60 to about 70 BCFU's, about70 to about 80 BCFU's, about 80 to about 90 BCFU's, about 90 to about100 or more BCFU's.

Under these criteria, the prebiotics can include, but are not limitedto, galacto-oligosaccharides, inulin and oligofructose(fructo-oligosaccharide), isomalto-oligosaccharides, lactulose,lactosucrose, transgalacto-oligosaccharides, soybean oligosaccharides,tagatose, xylo-oligosaccharides, and combinations thereof.

The prebiotic can be an oligosaccharide fructan including, but notlimited to, fructo-oligosaccharide and derivatives thereof of inulin(poly-D-fructose, itself derived from various plant products includingbananas, onions, chicory root, garlic, asparagus, barley, wheat, jicama,leeks, etc.) or from transfructosylation action of a β-fructosidase asused, for example, by Aspergillus sp. metabolically active on sucrose.In other embodiments, the prebiotics are derived from plants and plantproducts including, but not limited to, artichoke, dandelion greens,bran, flour, legumes, oats, citrus fruits, apples, and root vegetables,cane sugar, etc. If desired, the prebiotic also serves as a dietaryfiber source for the consumer or patient, but in certain conditions maybe depleted away from being a nutritional source for the probiotic.

Compositions described herein include prebiotics and probiotics formaintenance and treatment of gastrointestinal health. If desired,additional compounds are included in the functional food composition toimprove or maintain healthy conditions in the digestive tract.Additional compounds can be insoluble fibers and/or soluble fibersgenerally not specifically utilized by the probiotic; probiotic extracts(e.g., probiotic exudates and/or non-viable micro-organisms); digestiveenzymes including, but not limited to, pancreatin, pancrelipase, papain,pepsin, diatase, ox bile, lactase, protease, amylase, lipase, bromelain,cellulose, malt diastase, glucoamylase, hemicellulose, beta-gluconase,phytase, trypsin, aminopeptidase, chymotrypsin, carboxypeptidase,elastase, maltase, sucrose, etc.; supplements including, but not limitedto, glutamine, peppermint, artichoke, ginger, fennel, licorice root,anise seed; and compounds useful for immune health including, but notlimited to, vitamins (A, E, C, D); minerals (zinc, selenium); plantderived materials such as Echinacea, ashwaganda, elderberry, etc.; andyeast extracts.

Uses of Prebiotic/Probiotic Functional Foods

Edible transport compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases. This benefit can be provided to a consumer when newingredients or more of an existing ingredient are added to a food sothat an added health benefit from the food product is gained. Probioticsare useful for a variety of health related conditions as well as generalhealth maintenance. The effectiveness of probiotic treatment is enhancedthrough the use of a prebiotic that is consumed with a probiotic. Theedible transport compositions as described herein increase the effectivedelivered concentration of such useful probiotics, and can be formulatedfor daily dietary supplements, preventative treatment or treatment ofnosocomial infections, or for clinical applications treating systemicdisease states.

Often the probiotics are recommended by physicians and nutritionists totreat, for example, candidiasis, infections by opportunistic bacteriaestablishing after trauma, stress, excessive alcohol, exposure totoxins, lactose intolerance, or the establishment of normal flora aftertreatment with antibiotics. In some embodiments, the edible transportcompositions are used to assist the consumer's natural flora tore-establish and/or maintain normal concentrations in the stool and thedigestive tract. Often the probiotics are recommended by physicians andnutritionists to treat, for example, candidiasis, infections byopportunistic bacteria establishing after trauma, or the establishmentof normal flora after treatment with antibiotics. In some embodiments ofthe edible transport compositions, maintenance and/or treatment ofgastrointestinal conditions or disorders is provided through a regimenof daily consumption at high concentrations (50-100 BCFU's) for one totwo weeks followed by a maintenance treatment in a normal diet (1-10BCFU's) to assist in the re-establishment normal health conditions for aconsumer. Maintenance treatment in a normal daily diet (1-10 BCFU's) canbe useful for increasing transit times of stool though the intestinaltract, decreasing intestinal gas production and bloating, increasingmicroflora levels in the stool, and/or improving digestion. Otherconditions for which clinical changes and mitigation of intestinalsymptoms are desired can take longer treatments at higher concentrationsof the prebiotic and/or probiotic, for example 4-8 weeks.

Probiotics may play a role in the prevention of certain types of cancer(e.g. colon cancer) due to their ability to bind and metabolizecarcinogenic substances such as heterocyclic amines. Lower rates ofcolon cancer have been correlated with high consumption of fermenteddairy products. In some embodiments of the edible transportcompositions, maintenance and/or treatment is provided through a dailyregimen (1-10 BCFU's), which can be useful for contributing to theprevention of certain cancers.

Probiotics may play a role in benefitting the immune system by, forexample, competing against pathogens though competitive inhibition (e.g.opportunistic bacteria such as C. difficile), enhancing phagocytosis bywhite blood cells, and enhancing or increasing the production of certainantibodies and/or T-lymphocytes. Modulation of the immune system byregulating inflammatory and hypersensitivity responses related tocytokine regulation and function is also found to be correlated tointake of probiotics, as is the management of diarrhea and inflammatorybowel disease. In some embodiments of the edible transport compositions,maintenance and/or treatment of immune response conditions or disordersis provided through a regimen of daily consumption at highconcentrations (50-100 BCFU's) for one to two weeks followed by amaintenance treatment in a normal diet (1-10 BCFU's) to assist in there-establishment of normal health conditions for a consumer. Maintenancetreatment in a normal daily diet (1-10 BCFU's) can be useful formanagement of diarrhea and inflammatory bowel disease.

Probiotics may play a role in the treatment for systemic disorders suchas high cholesterol and high blood pressure. Ingestion of sufficientlevels of probiotics is correlated with lowering cholesterol through amechanism thought to be involved with the breakdown of bile in theintestinal tract to a metabolite that is unable to be reabsorbed.Additionally, reduction in blood pressure has been correlated withintake of fermented dairy products. Thus, it is believed thatangiotensin-converting-enzyme inhibitors or inhibitor like peptides areproduced by the probiotic. Maintenance treatment in a normal daily diet(1-10 BCFU's) can be useful for management of systemic disorders such ashigh cholesterol and/or high blood pressure.

II. Overview of the Functional Nutrition Compositions for IntegumentHealth

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, provide nutritional supplements and anincrease in general health, beauty and well-being. The functional foodcomposition contains an edible or potable substance that is encapsulatedin an edible membrane, and further contains an integument healthcompound comprising bioflavonoids, carotenes and an elastic tissuecomponent supplementing a normal diet. The functional food compositionsdescribed herein provide a convenient and improved way for individualsto consume bioflavonoids, carotenes and an elastic tissue component incombinations and/or sufficient quantities needed to supplement normaldiet, promote and/or maintain integument health, treat conditionsparticularly related to integument health, and increase general health,beauty and well-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health maintenanceand promotion, disease prevention, etc. Some benefits arise fromproviding an important nutritive food source, vitamins and supplementsand/or compounds such as bioflavonoids, carotenes and elastic tissuecomponents that generally or specifically contribute to increased healthand beauty. A higher degree of health assists in the prevention,management and treatment of acute or chronic diseases or disorders. Thishealth and beauty improvement or benefit can be provided to a consumerwhen additional ingredients or more of an existing ingredient are addedto a food so that the benefit from the food composition is gained.However, delivery systems for some bioavailable compounds, includingthose important for supplementing a diet, can reduce the viability ofthe compounds, resulting in suboptimal quantities of these compoundsbeing made available to the consumer for a particular food composition.Often, the delivery system for a nutritional supplement is in a forminsufficient to promote compliance in a particular consumer group (e.g.,elderly, infirm, children and young adults), such as being in a largepill form, powder form with little gustatory appeal, or poor tastingliquids.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofbioflavonoids, carotenes and elastic tissue components useful to aconsumer. Within these compositions, the bioflavonoids, carotenes andelastic tissue components can be compartmentalized within the edible orpotable substance, the encapsulating membrane, or both. Upon masticationand ingestion, the bioflavonoids, carotenes and elastic tissuecomponents are released from the functional food composition to providean immediately available nutrition and edible source. The functionalfood compositions can thus be designed to have one or morebioflavonoids, carotenes and elastic tissue components in an effectivecombination and concentration desirable for the specific needs of theconsumer or patient, for example, the elderly, adult and childrenconsumers, and medical patients.

The functional food compositions described herein are designed toprovide bioflavonoids, carotenes and elastic tissue components inbiologically effective quantities for promoting integument healthsuperior to commonly used products. The compositions are particularlywell-suited for providing a larger active ingredient load as well asbeing amenable for controlling the actual portion size for an intendedhealth benefit. Functional food compositions as described herein canprovide up to and above several times the suggested minimum dosages in asample serving, or provide combinations of bioflavonoids, carotenes,elastic tissue components, nutraceuticals and supplements up to andabove several times the suggested minimum dosages in a single servingthat is both convenient and appetizing. A functional food delivering acombination of integument health compounds in a single servingcomposition can result in the cessation or mitigation of a multitude ofskin related conditions (e.g., wrinkles, dry skin, brittle nails, hairloss, skin spots, etc.), supplement dietary imbalance, and promote usercompliance in the daily consumption of these and other health promotingcompounds. In addition, a general state of beauty, health and wellnesscan result from a healthy diet supplemented with these and other healthpromoting compounds.

Population segments that may find useful a bioflavonoids, carotenes andelastic tissue component functional food composition as described hereininclude the elderly, adults, hospital patients, and those with a varietyof skin conditions such as wrinkles, dryness, etc.

Consumers and patients can become noncompliant for daily intake ofhealth compounds depending on the delivery form of the composition. Forexample, some health compounds are in pill form with a flavor, textureand overall size (e.g., omega-3 and omega-6 fatty acids, multivitaminsupplements, etc.) that often result in reluctance to consume on ascheduled or daily basis. Therefore, a functional food as describedherein that delivers a daily concentration of integument healthcompounds can overcome non-compliance.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc., inaddition to bioflavonoids, carotenes and elastic tissue components, byencapsulating the substance within edible or biodegradable membranes,for which the membranes provide barriers to oxygen and oxygendegradation, diffusion, etc. The edible membranes of these compositionscan be formed from various natural polymeric substances that allow thecompositions to be easily transported and consumed by a consumer.

Various bioflavonoids, carotenes, elastic tissue components,supplements, and nutraceuticals can be included in the functional foodcompositions described herein in quantities sufficient to correlate withrecommended daily allowances, for the maintenance of integument health,treatment and prevention of integument disorders and related conditions,and are beneficial supplementations to normal dietary intake.

Aging, metabolic and hormonal changes related to aging, exposure toenvironmental conditions (sun exposure, arid environments), etc., canall contribute to changes in skin appearance and health. Metabolicchanges, although natural, can result in decreased production ofcollagen and/or elastin that affect the overall appearance and textureof skin, nails and hair. Environmental exposure such as ultraviolet (UV)radiation also damages skin cells and hair. Over the longer term, UVradiation induces degenerative changes in cells of the skin, fibroustissue and blood vessels leading to premature skin aging and wrinkles,lentigo, etc. UV exposure directly affects the bilayer making up a cellmembrane because it is made up of a significant amount of unsaturatedlipids that are more prone to attack by free radicals. Damage by freeradicals is assumed to be one of the causative factors of aging,inflammation and hyper pigmentation. In fact, the stratum corneum hasbeen found to produce significant concentrations free radicals under UVexposure, damaging DNA, lipids, proteins and carbohydrates. Nitric oxideand reactive oxygen species (ROS) including superoxide anion andhydrogen peroxide are highly reactive oxidant molecules produced by thehuman body through normal metabolism and diet, and also may play a rolein certain conditions including the loss of elasticity in skin.Antioxidants are protective compounds that inactivate ROS and delay orprevent oxidative damage.

Lycopene is a natural carotene found in tomato, and functions at leastas an antioxidant or oxygen scavenger. It is a powerful antioxidant andanti-inflammatory, with activity twice as high as that of β-carotene andtenfold higher than α-tocopherol, that can aid in protecting integumentfrom environmental agents as well as contribute to healthy maintenanceof texture and appearance. Studies suggest that ingestion of lycopenecontributes to increased protection from sunburn, and that higherconcentrations of lycopene in cutaneous skin layers enhance a softerskin texture. Therefore, a functional food composition rich in lycopenecan contribute to more pleasant skin texture, youthful skin appearance,beauty and the mitigation of free radical damage.

Medical investigations provide that regular consumption offlavonoid-containing foods also can reduce the risk of oxidative damageas is found from skin damage or aged appearance of the integument. Whilebioflavonoids are ubiquitous in plants, cocoa (Theobroma cacao) and tea(Camellia sinensis) have been found to be particularly rich in asub-class of flavonoids known as flavanols. A number of human dietaryintervention trials with flavanol-containing cocoa and tea products havedemonstrated improvements in systemic function from conditions relatedto oxidative damage. Flavanols are also found in fruits and vegetablesand are linked to certain health benefits. As with lycopene othercarotenes, flavanols are thought to take part in mechanisms such asnitric oxide and antioxidant, anti-inflammatory, and antiplateleteffects to improve endothelial function, lipid levels, particularly withrespect to preventing the oxidization of unsaturated lipids. Therefore,a functional food product rich in bioflavanoids can contribute tomitigating the effect of free radical damage on the integument, youthfulskin appearance, beauty, and maintenance of integument health andwell-being.

Collagen is a group of naturally occurring proteins found in theintegument and connective tissues of animals, making up about one thirdof the whole-body protein content. Collagen occurs in many placesthroughout the body and comprises the main component of connectivetissue. Many types of collagen are known, the most common being collagenI (integument, tendon, vascular ligature, organs, the main component ofthe organic part of bone), collagen II (main component of cartilage),collagen III (main component of reticulate fibers and commonly foundalongside type I), collagen IV (forming the bases of cell basementmembrane), and collagen V (cell surfaces, hair and placenta).Collagen-related diseases most commonly arise from genetic defects ornutritional deficiencies that affect the biosynthesis, assembly,post-translational modification, secretion, or other processes involvedin normal collagen production. Hydrolyzed and non-hydrolyzed type IIcollagen, often in combination with other joint and cartilage healthcompounds, can be used for joint pain relief and treatment of arthritisand other joint conditions and diseases. Elastin is a protein inconnective tissues that provides mechanical strength and elasticcharacter, allowing tissues to resume a resting state shape afterstretching or contracting. Elastin is a significant componentparticularly in the skin. As both collagen and elastin are significantelastic tissue components of the skin, a functional food product rich inelastin and collagen may contribute to more pleasant skin texture,youthful skin appearance, beauty, and maintenance of integument healthand well-being.

The functional food compositions with bioflavonoids, carotenes andelastic tissue components described herein include, but are not limitedto, bioavailable forms of bioflavonoids, carotenes and elastic tissuecomponents, bioactive derivatives thereof, salts thereof, and bioactivemetabolic intermediates.

Other compounds can be used exclusively or in combination withbioflavonoids, carotenes and elastic tissue components of the functionalfood compositions described herein. Nutraceuticals are generally thoughtof as food or food product that reportedly provide health and medicalbenefits, including the prevention and treatment of disease, and can bedefined as a product isolated or purified from foods that is generallysold in medicinal forms not usually associated with food. Anutraceutical may have a physiological benefit or provide protectionagainst chronic disease. Such nutraceutical products may range fromisolated nutrients, vitamins and minerals, other dietary supplements,and herbal products. With recent developments in cellular-levelnutraceutical agents, researchers, and medical practitioners aredeveloping templates for integrating and assessing information fromclinical studies on complementary and alternative therapies intoresponsible medical practice.

Functional Food Compositions with Bioflavonoids, Carotenes and ElasticTissue Compounds for Integument Health and Maintenance

In general antioxidants contemplated for use for the functional foodcomposition as described herein can include, without limitationcarotenes, bioflavonoids (flavonoids, isoflavones, neoflavonals),tocopherol, tocotrienol, lipoic acid, melatonin, superoxide dismutase,coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, seleniumand ascorbic acid. Carotenes contemplated for use as membrane particlesinclude α-carotene, β-carotene, γ-carotene, δ-carotene, ε-carotene,lycopene, cryptoxanthin, lutein, zeaxathin, apocarotenal astaxanthin,canthaxanthin, lutein/lutein esters, etc. If desired, the amount ofcarotene in the functional food composition serving as described hereincan be up to about 1 milligram (mg), up to about 5 mg, up to about 10mg, up to about 15 mg, up to about 20 mg, up to about 25 mg, up to about30 mg, up to about 35 mg, up to about 35 mg, up to about 40 mg, up toabout 45 mg, up to about 50 mg, up to about 60 mg, up to about 70 mg, upto about 80 mg, up to about 90 mg, up to about 100 mg. Bioflavonoid usedfor the functional food composition described herein include esveratrol,quercetin, rutin, catechin, epichatechins, proanthocyanidins, andcombinations thereof. Bioflavonoids can be derived from various plantsincluding, for example, Camellia sinensis, Theobroma cacao (cocoaflavanols) and species, varieties, cultivars, thereof. Bioflavonoids canalso be derived from or found in various plant extracts including, butnot limited to, acai berry extract, raspberry extract, cranberryextract, pomegranate extract, plum extract, cherry extract, rosemaryextract, etc. Isoflavones are used as membrane particles, including, butnot limited to, genistein, daidzein, biochanin A, and formononetin. Ifdesired, the amount of bioflavonoid in the functional food compositionserving as described herein can be up to about up to about 50 mg, up toabout 100 mg, up to about 150 mg, up to about 200 mg, up to about 250mg, up to about 300 mg, up to about 350 mg, up to about 400 mg, up toabout 450 mg, up to about 500 mg, up to about 600 mg, up to about 700mg, up to about 800 mg, up to about 900 mg, up to about 1000 mg.

Generally, collagen compounds comprising type II and/or hydrolyzed typeII collagen and elastin, both commercially available, have been shown tobe useful for maintenance and treatment of integument condition. Ifdesired, the amount of collagen provided in an integument healthfunctional food composition can be sufficient for a recommended dailyintake, for example, up to 1000 mgs total, up to about 2000 mgs total,up to about 3000 mgs total, up to about 4000 mgs total, up to about 5000mgs total, up to about 6000 mgs total, up to about 7000 mgs total, up toabout 8000 mgs total, up to about 9000 mgs total, up to about 10,000mgs. If desired, the amount of elastin provided in an integument healthfunctional food composition can be sufficient for a recommended dailyintake, for example, up to about 500 mgs, up to 1000 mgs total, up toabout 2000 mgs total, up to about 3000 mgs total, up to about 4000 mgstotal, up to about 5000 mgs total, up to about 6000 mgs total, up toabout 7000 mgs total, up to about 8000 mgs total, up to about 9000 mgstotal, up to about 10,000 mgs.

Uses of Functional Food Compositions for Integument Health

Functional food compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state, as well asprovide a source of bioflavonoids, carotenes and elastic tissuecomponents for integument health, treatment and maintenance. Thesebenefits can be provided to a consumer when new ingredients or more ofan existing ingredient are added to a food so that an added healthbenefit from the food product is gained.

Supplementing a diet with bioflavonoids, carotenes and elastic tissuecomponents deliverable in the functional foods as described herein isuseful for prevention and treatment of a variety of conditions anddisorders, particularly those related to skin appearance (wrinkles,dryness, skin spots), brittle nails, hair loss, as well as for generalhealth and beauty maintenance.

The functional food compositions as described herein increase theeffective delivered concentration of such useful bioflavonoids,carotenes and elastic tissue components, and can be formulated for dailydietary supplements, preventative treatment of integument damage (UVlight, aridity), and other disorders related to environmental damage andaging.

III. Overview of the Functional Nutrition Compositions for Weight Loss

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, promote weight loss and an increase ingeneral health and well-being. The functional food composition containsan edible or potable substance that is encapsulated in an ediblemembrane, and further contains compounds for promoting weight loss. Thefunctional food compositions described herein provide a convenient andimproved way for individuals to consume weight loss compounds incombinations and/or sufficient quantities needed to promote weight lossand an increase in general health and well-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits arise from providing an importantnutritive food source, vitamins and supplements and/or compounds thatgenerally or specifically contribute to increased health. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases or disorders. This health improvement benefitcan be provided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood composition is gained. However, delivery systems for somebioavailable compounds, including those important for weight loss, canreduce the viability of the compounds, resulting in suboptimalquantities of these compounds being made available to the consumer for aparticular food composition.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofcompounds useful for weight loss available to a consumer. Within thesecompositions, the weight loss compounds can be compartmentalized withinthe edible or potable substance, the encapsulating membrane, or both.Upon mastication and ingestion, the weight loss compounds are releasedfrom the functional food composition to provide an immediately availablenutrition and edible source that promotes weight loss. The functionalfood compositions can thus be designed to have one or more weight losscompounds in an effective combination and concentration desirable forthe specific needs of the consumer or patient, for example, overweightor obese elderly, adult and children consumers, and medical patients.

The functional food compositions described herein are designed toprovide weight loss compounds in biologically effective quantitiessuperior to commonly used products. The compositions are particularlywell-suited for providing a larger active ingredient load as well asbeing amenable for controlling the actual portion size for an intendedhealth benefit. Functional food compositions as described herein canprovide up to and above several times the suggested minimum dosages in asimple serving, or provide combinations of weight loss compounds,vitamins and supplements up to and above several times the suggestedminimum dosages in a single serving that is both convenient andappetizing. A functional food delivering a combination of vitamins,supplements and weight loss compounds in a single product can result inthe cessation or mitigation of a multitude of health related conditionsand diseases. In addition, a general state of health and wellnessresulting from weight loss can lead to a better psychologicalpresentation as social pressures, medical issues and financialimplications of excess and persistent weight can lead to a generaldecline in happiness and well-being.

Population segments that may find useful a weight loss composition asdescribed herein include the elderly, adults and youth in addition tohospital patients. These consumers and patients can become susceptibleto high cholesterol and blood pressure, heart disease, diabetes,increased risk of stroke, heart attack and cancer, depression, bone andcartilage disease and disorders, gastrointestinal disorders, respiratoryproblems and systemic disorders including those related to nephrologyand urology.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc. andweight loss compounds, by encapsulating the substance within edible orbiodegradable membranes, for which the membranes provide barriers tooxygen, diffusion, etc. The edible membranes of these compositions canbe formed from various natural polymeric substances that allow thecompositions to be easily transported and consumed by a consumer.

Various supplements, nutraceuticals and products for weight loss alsocan be included in the functional food compositions described herein inquantities sufficient to correlate with increased state of health andbeneficial treatment of weight related disorders, in a form thatprovides a tasty and delicious gustatory experience. The functional foodcompositions for use in weight loss regimens and general nutritiondescribed herein include, but are not limited to, bioavailable forms ofappetite suppressants, acting to manipulate hormonal and chemicalprocesses in the body that otherwise increase hunger and/or the sense offeeling satiated (e.g., anorectics such as epinephrine andnorepinephrine/noradrenaline), fat or cholesterol uptake inhibitors(such as green tea extract), gastrointestinal fillers, and thermogeneiccompounds which boost a normal metabolic rate of the individual andresult in metabolism of fat stores. Weight loss compounds can besynthetic or natural.

Some compounds, for example thylakoids and thylakoid extracts, are knownto elicit more than one effect, for example regulating enzymes importantfor appetite control (e.g., appetite signaling proteins including asghreilin or satiety signaling proteins including leptin), stericinterference by binding to fat molecules for uptake inhibition,attenuating glucose uptake, and as a gastrointestinal filler, all ofwhich are contemplated for use in the present invention.

Generally, the weight loss functional food compositions as describedherein can use thylakoid compounds and/or extracts. Ingestion ofthylakoids results in the suppression of appetite, contributing tosatiety, as well as contributing to binding of fat molecules. The neteffect is the temporal delay of fat digestion in the gut and thetriggering of natural satiety signals that affect feeding behavior andeating patterns. A regimen that includes thylakoid and/or thylakoidextracts can thus result in the induction of weight loss by theconsumer.

Other compounds can be used exclusively or in combination with weightloss described herein for functional food compositions described herein.If desired, such weight loss compounds include, but are not limited to,satiety inducing compounds and fat uptake inhibitors such as proteinaseinhibitor II, green coffee bean extract, chlorogenic acid, green tealeaf extract, polyphenols, ashwagandha extract, xanthum gum, andpinolenic acid, hoodia, chitosan, chromium picolinate, conjugatedlinoleic acid, glucomannan, green tea extract, guar gum, guarana,guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract,vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia,hoodia, L-carnitine, raspberry ketones, banana leaf, red clover, ginger,almonds, acai berry, flax seeds, leucine, and lipodrene.

Additionally, weight loss functional foods as described herein may befortified with additional supplements, minerals and/or nutrients,including essential amino acids, vitamins and minerals, anti-oxidants,and essential fatty acids.

In general, a reduction in weight through the consumption of weight lossfunctional foods as described herein can lead to mitigation andtreatment of weight related disorders and diseases, improvement inquality of life and ability to perform activities of daily living, andmeasurable differences in various health indicators (including, forexample, obesity, high cholesterol levels, high blood pressure,mitigation and cessation of adult-onset diabetes, etc.).

Weight Loss Compositions

Compounds in concentration and/or type contained within the functionalfood compositions included herein may be used in addition to naturallevels of weight loss compounds in the food source.

Generally, thylakoids, thylakoid extracts and bioavailable and bioactivemetabolic derivatives and/or complexes can be included in membranesencapsulating an edible or potable substance and/or within the edible orpotable substance. Concentrated, isolated and purified thylakoidcompositions and thylakoid extracts are commercially available. Certainthylakoid compositions and/or extracts are isolated from spinach leaves.However, any concentrated and/or purified thylakoids compounds andextracts from any plant or microbiological source (for example,cyanobacteria) are contemplated for use with these functional foods. Ifdesired, the amount of purified thylakoid composition or extractprovided in a weight loss functional food composition sufficient for aneffective daily intake can be, for example, up to 1 gram (g) total, upto about 2.5 g total, up to about 5 g total, up to about 7.5 g total, upto about 10 total, up to about 12.5 g total, up to about 15 g total, upto about 17.5 g total, up to about 20 g total, up to about 22.5 g total,up to about 25 g total, up to about 27.5 g total, up to about 30 gtotal.

If desired, other weight loss compositions can be included in thefunctional food compositions described herein. Other compounds caninclude, without limitation, proteinase inhibitor II, green coffee beanextract, chlorogenic acid, green tea leaf extract, polyphenols,ashwagandha extract, xanthum gum, and pinolenic acid, hoodia, chitosan,chromium picolinate, conjugated linoleic acid, glucomannan, green teaextract, guar gum, guarana, guggal, senna, ephedra, bitter orange,fucoxanthin, white bean extract, vitamin D, human chorionicgonadotropin, resveratrol, capsaicin, chia, hoodia, L-carnitine,raspberry ketones, banana leaf, red clover, ginger, almonds, acai berry,flax seeds, leucine, and lipodrene.

Generally, other compounds and/or bioavailable metabolic derivatives caninclude vitamins (for example, vitamin A, vitamin B, vitamin C, vitaminD, vitamin E, vitamin K, etc), minerals (for example calcium, iron,copper, zinc, magnesium, manganese, phosphorus, potassium, etc.),essential fatty acids (for example, omega-3-fatty acid, omega-6-fattyacid, etc.), essential amino acids (L-histidine, L-isoleucine,L-leucine, L-lysine, L-methionine, L-phenylalanine, L-valine andL-threonine), antioxidant agents and anti-inflammatory agents.

Uses of Edible Compositions for Weight Loss and Target WeightMaintenance

Edible transport compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state. This benefitcan be provided to a consumer when new ingredients or more of anexisting ingredient are added to a food so that an added health benefitfrom the food product is gained. Weight loss compounds such thylakoids,thylakoid extracts, proteinase inhibitor II, green coffee bean extract,chlorogenic acid, green tea leaf extract, polyphenols, ashwagandhaextract, xanthum gum, and pinolenic acid, hoodia, chitosan, chromiumpicolinate, conjugated linoleic acid, glucomannan, green tea extract,guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin,white bean extract, vitamin D, human chorionic gonadotropin,resveratrol, capsaicin, chia, hoodia, L-carnitine, raspberry ketones,banana leaf, red clover, ginger, almonds, acai berry, flax seeds,leucine, and lipodrene are useful for prevention and treatment of avariety of conditions and diseases as well as general healthmaintenance. The effectiveness of weight loss treatment and healthyweight maintenance is enhanced through the use of an efficient deliverysystem. The functional food compositions as described herein increasethe effective delivered concentration of such useful weight losscompositions, and can be formulated for daily dietary supplements,preventative treatment or for clinical applications treating systemic orchronic disease states and disorders.

Supplementing daily dietary intake with weight loss compounds as acomponent of the functional food composition contributes to maintenanceof healthy weight or loss of excess weight. Persons of all agespotentially can find useful these compositions, to prevent weight gainor as part of a daily regimen for weight loss. Various diseases andconditions can present in a consumer or patient from obesity and beingoverweight, and thus are targeted for mitigation though consumption ofthese functional foods, including high cholesterol and blood pressure,heart disease, diabetes, increased risk of stroke, heart attack andcancer, depression, bone and cartilage disease and disorders,gastrointestinal disorders, respiratory problems and systemic disordersincluding those related to nephrology and urology.

Maintenance treatment in a daily diet with functional food compositionsdirected to general weight maintenance and diet (up to about 5 gthylakoid or thylakoid extract) can be useful for the prevention ofweight gain or treatment for weight loss, and contribute to generalhealth and wellness of the consumer. Ideal weights can be estimatedfrom, for example, a Body Mass Index (BMI) calculation ([weight(pounds)/height² (inches)]×703). BMI ranges are given by, for example,the Centers for Disease Control, to provide guidance on ideal BMI andtarget weights that are not considered “obese” and “overweight.” SuchBMI indicators indicating “overweight” an “obese” have been correlatedto the onset of chronic diseases and disorders. Examples of BMI rangesinclude: Underweight is less than 18.5, normal weight is 18.5 to 24.9,overweight is 25 to 29.9, obese is greater than 30.

IV. Overview of the Functional Nutrition Compositions for SkeletalHealth

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, promote skeletal structure health andwell-being and maintenance of bone structure. The functional foodcomposition contains an edible or potable substance that is encapsulatedin an edible membrane, and further contains compounds for skeletalstructure health. The functional food compositions described hereinprovide a convenient and improved way for individuals to consume bonehealth compounds in combinations and/or sufficient quantities needed topromote skeletal structure health and well-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits arise from providing an importantnutritive food source, vitamins and supplements and/or compounds thatgenerally or specifically contribute to increased health. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases or disorders. This health improvement benefitcan be provided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood composition is gained. However, delivery systems for somebioavailable compounds, including those important for skeletal health,can reduce the viability of the compounds, resulting in suboptimalquantities of these compounds being made available to the consumer for aparticular food composition.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofcompounds useful for skeletal health and maintenance available to aconsumer. Within these compositions, the skeletal health compounds canbe compartmentalized within the edible or potable substance, theencapsulating membrane, or both. Upon mastication and ingestion, theskeletal health compounds are released from the functional foodcomposition to provide an immediately available nutrition source. Thefunctional food compositions can thus be designed to have one or moreskeletal health compounds in an effective combination and concentrationdesirable for the specific needs of the consumer or patient, forexample, elderly, children, and medical patients.

The functional food compositions described herein are designed toprovide skeletal health compounds in biologically effective quantitiessuperior to commonly used products. The compositions are particularlywell-suited for providing a larger active ingredient load as well asbeing amenable for controlling the actual portion size for an intendedhealth benefit. Functional food compositions as described herein canprovide up to and above several times the suggested minimum dosages in asimple serving, or provide combinations of skeletal health compounds,vitamins and supplements up to and above several times the suggestedminimum dosages in a single serving that is both convenient andappetizing. A functional food delivering a combination of vitamins,supplements and skeletal health compounds in a single product canbenefit from a resulting synergistic interaction, as has beenidentified, for example, in patients having hormone therapy/replacementor when used by postmenopausal patients. Population segments that mayfind useful a functional food skeletal health composition as describedherein include the eldery susceptible to osteoporosis, persons who maynot receive a sufficient amount of sunlight to stimulate natural vitaminD production (darker skinned people, infants, pregnant women, etc.),children suffering from osteomalacia, and the like.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc. andskeletal health compounds, by encapsulating the substance within edibleor biodegradable membranes, for which the membranes provide barriers tooxygen, diffusion, etc. The edible membranes of these compositions canbe formed from various natural polymeric substances that allow thecompositions to be easily transported and consumed by a consumer.

Various supplements, nutraceuticals and products for skeletal healthalso can be included in the functional food compositions describedherein in quantities sufficient to correlate with increased state ofhealth and beneficial treatment of bone and skeletal structuredisorders, in a form that provides a tasty and delicious gustatoryexperience. The functional food compositions for use in skeletal healthand nutrition described herein include, but are not limited to,bioavailable forms of vitamin D and/or other calcium uptake enhancers,calcium/calcium salts, magnesium/magnesium salts, vitamin K compounds,etc.

Vitamin D (comprising colecalciferol and ergocalciferol) has long beenknown to be important for enhancing calcium and phosphorous uptake inthe intestinal tract. Vitamin D is a fat-soluble vitamin that isnaturally available in some foods and can be ingested in dietarysupplement form. Humans can also produce vitamin D when ultraviolet raysfrom sunlight strike the skin to initiate vitamin D synthesis. Vitamin Dis biologically inert and must undergo two hydroxylations in the bodyfor activation (vitamin D to 25-hydroxyvitamin D (calcidiol) to1,25-dihydroxyvitamin D (calcitriol), the latter being physiologicallyactive). Vitamin D assists in intestinal calcium absorption for themaintenance of calcium and phosphate concentrations for skeletal health,bone growth and the prevention of, for example, hypocalcemic tetany.Without an adequate vitamin D concentration in the body, bones canbecome thin, brittle, or misshapen.

If desired for a particular application, the form of vitamin D and/ormetabolic and bioactive/bioavailable derivatives thereof can be providedin the edible or potable substance, and/or in membranes as, for example,powdered form, micelles and/or as particulates. Inclusion of particlesin the membrane can also contribute to performance enhancement(increased strength, preferable mouth-feel and flavor, permeabilitypreferences, etc.) of the membrane.

Vitamin K was shown to have a positive impact on bone building,especially when taken with calcium and vitamin D. Vitamin K biologicallyactivates osteocalcin, which enables calcium incorporation into theproper three-dimensional structure of bone. Vitamin K refers to a groupof menaquinone compounds including Vitamin K₁, and Vitamin K₂ which isfurther comprised of, for example, short chain menaquinones (e.g., MK-4)and long chain menaquinones (e.g., MK-7, MK-8, and MK-9). Gla-proteinsare dependent on Vitamin K proteins, and are synthesized in a variety oftissue types. In particular for bone health, osteocalcin is anon-collagenous protein secreted by osteoblasts and plays an essentialrole in the formation of mineral in bone and maintenance of bone mineraldensity, and may be particularly important as a supplement in menopausalwomen. Matrix Gla-protein is a calcification inhibitory protein alsofound in numerous body tissues, and has a pronounced role in cartilagemaintenance.

There are two commonly recognized kinds of vitamin K deficiency: acuteand chronic. Acute deficiency can be manifested as unusual bleeding fromgums, nose, and/or the gastrointestinal tract. The results of acutedeficiency are often severe and can include internal clogging of theblood vessels resulting in strokes, embolism, lung damage, and in severecases, death caused by immoderate blood loss. Chronic vitamin Kdeficiency is less obvious than acute deficiency and potentially puts anindividual at higher risk because there are no obvious symptoms. Chronicvitamin K deficiency can result in impairments in bone, cardiovascularhealth, and other disease of aging. Therefore, supplementing a diet withvitamin K in a functional food composition as described herein cancontribute to proper development of bone, thereby decreasing, forexample, the potential for bone fractures due to poor skeletal health,development of osteoporosis, and also contribute to improvedcardiovascular health.

Calcium and magnesium are available in some foods, medicines, and as adietary supplement. Almost all of the body's calcium supply is stored inthe bones and teeth to support structure and function, whereas abouthalf of the body's supply of magnesium is in the bones. Bone undergoescontinuous restructuring and functions with constant resorption anddeposition of calcium into new bone, with the extent of boneresorption/deposition changing depending on physical stresses and age.In older adults, the breakdown of bone exceeds resorption/deposition andcan result in the development of osteoporosis. Additionally, calcium isrequired for other bodily and cellular functions including vascularcontraction and vasodilation, muscle function, nerve transmission,intracellular signaling and hormonal secretion. Magnesium is needed forhundreds of biochemical reactions in the body, maintenance of normalmuscle and nerve function, a healthy immune system, and bone integrity.Magnesium is also involved with blood sugar and blood pressureregulation, energy metabolism and protein synthesis. Generally, theseand other compositions known to be necessary for bone health can beincluded in a functional food composition for increasing skeletalhealth.

Beneficial aspects of skeletal health that are commonly sought includeincreased bone density and strength, modulation of cell growth,neuromuscular and immune function, reduction of inflammation, and theregulation of certain enzyme activities. Functional food compositionsspecific to bone and skeletal structure contribute to diseaseprevention, for example rickets, osteomalacia, and osteoporosis, inaddition to the general health and wellness of the skeletal supportstructure. Measurable outcomes for general health maintenance can bedetermined qualitatively and/or quantitatively by monitoring, forexample, a patient's or consumer's change in bone density, blood levelconcentrations of vitamin K, vitamin D, calcium, and or magnesium,possible feelings of well-being, and decreasing levels of chronic jointand skeletal pain. For pretreatment/prevention of diseases, conditionsand/or syndromes, the consumer or patient may show milder symptoms or nosymptoms. In acute conditions for which the consumer or patient is usingthe functional food composition, for example acute vitamin K deficiency,the outcome would be faster resolution of symptoms (e.g., cessation ofbleeding gums) and reduction in symptom severity during and aftertreatment. For chronic conditions such as osteoporosis or osteomalacia,a patient or consumer would show measurable increase in bone density andcritical blood concentration of metabolites, for example, calcium andmagnesium. In general, a reduction in pain and discomfort, improvementin quality of life and ability to perform activities of daily living,and measurable differences in concentration of metabolites or bonedensity are all indicators of the health benefits when consuming thefunctional food compositions for skeletal health described herein.

Skeletal Health Compositions

Compounds in concentration and/or type contained within the functionalfood compositions included herein may be used in addition to naturallevels of skeletal health compounds in the food source.

Generally, vitamin D, its bioavailable and bioactive metabolicderivatives and/or complexes can be included in membranes encapsulatingan edible or potable substance and/or within the edible or potablesubstance. If desired, the amount of vitamin D provided in a skeletalhealth functional food composition can be sufficient for a recommendeddaily intake, for example, up to about 500 International Units (IU), upto about 1000 IU, up to about 2000 IU, up to about 3000 IU, or up toabout 4000 IU.

Generally, any one or combination of calcium compounds and/or salts areincorporated into the membrane and/or edible or potable substance,including, but not limited to, calcium acetate, calcium carbonate,calcium citrate, calcium citrate malate, calcium gluconate, calciumlactate, calcium lactogluconate, and tricalcium phosphate. If desired, askeletal health functional food composition can provide up to about 200mgs total, up to about 400 mgs total, up to about 600 mgs total, up toabout 800 mgs total, up to about 1000 mgs total, up to about 1200 mgstotal of one or more bioavailable calcium compounds.

Generally, magnesium compounds and/or salts are incorporated into themembrane and/or edible or potable substance, including magnesiumascorbate, magnesium aspartate, magnesium bicarbonate, magnesiumcarbonate, magnesium chloride, magnesium citrate, magnesium fumarate,magnesium gluconate, magnesium glutamate, magnesium glycinate, magnesiumhydroxide, magnesium lactate, magnesium lysinate, magnesium malate,magnesium orotate, magnesium oxide, magnesium phosphate, magnesiumpidolate, magnesium taurate, and magnesium sulfate (or magnesiumsulphate). If desired, a skeletal health functional food composition canprovide up to about 80 milligrams (mgs), up to about 100 mgs, up toabout 120 mgs, up to about 140 mgs, up to about 160 mgs, up to about 180mgs, up to about 200 mgs, up to about 220 mgs, up to about 240 mgs, upto about 260 mgs, up to about 280 mgs, up to about 300 mgs, up to about320 mgs.

Generally, combinations of calcium compounds and/or salts, magnesiumcompounds and/or salts, and/or calcium uptake compounds can be includedin the functional food composition as described herein. In general it isdesirable that the form of calcium compounds and/or salts, magnesiumcompounds and/or salts, and/or calcium uptake compounds and/orbioavailable metabolic derivatives (e.g., in powdered form, micelles,etc.) is provided in the membranes and contributes to performanceenhancement of the membrane. If desired, in addition to or alternativelyto vitamin D as a calcium uptake compound, other calcium uptakecompounds can be used in the functional food composition, including, butnot limited to, calcitonin, albumin and parathyroid hormone (PTH),effectors of PTH release, and combinations, bioavailable and bioactivederivatives and/or metabolic intermediates of these compounds.

Generally, vitamin K₁ and/or vitamin K₂ compounds and/or bioavailablemetabolic derivatives are incorporated into the membrane and/or edibleor potable substance. In general it is desirable that the form ofvitamin K and/or bioavailable metabolic derivatives (e.g., powderedform, micelles, etc.) is provided in the membranes and contributes toperformance enhancement of the membrane. Some applications of thefunctional food compositions can provide up to about 5 micrograms, up toabout 75 micrograms, up to about 100 micrograms, up to about 200micrograms, up to about 300 micrograms, up to about 400 micrograms, upto about 500 micrograms of vitamin K₁ and/or vitamin K₂ compounds and/orbioavailable and bioactive metabolic derivatives.

Uses of Edible Compositions for Skeletal Health and Maintenance

Edible transport compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases. This benefit can be provided to a consumer when newingredients or more of an existing ingredient are added to a food sothat an added health benefit from the food product is gained. Skeletalhealth related compounds or supplements such as Vitamin D, Vitamin K,calcium and magnesium are useful for a variety of conditions anddiseases as well as general health maintenance. The effectiveness ofskeletal health treatment and maintenance is enhanced through the use ofan efficient delivery system. The functional food compositions asdescribed herein increase the effective delivered concentration of suchuseful skeletal health compositions, and can be formulated for dailydietary supplements, preventative treatment or for clinical applicationstreating systemic disease states.

There are two commonly recognized kinds of vitamin K deficiency: acuteand chronic. Acute deficiency can be manifested as unusual bleeding fromgums, nose, and/or the gastrointestinal tract. The results of acutedeficiency are often severe and can include internal clogging of theblood vessels resulting in strokes, embolism, lung damage, and in severecases, death caused by immoderate blood loss. Infants are considered tobe at an increased risk for acute vitamin K deficiency, because vitaminK is not transported sufficiently across the placenta. Chronic vitamin Kdeficiency is less obvious than acute deficiency and potentially puts anindividual at higher risk because there are no obvious symptoms. Chronicvitamin K deficiency can result in impairments in bone, cardiovascularhealth, and other disease of aging.

Supplementing daily dietary intake with skeletal health compounds as afunctional food contributes to maintenance of new bone, an importanthealth concern that increases with physical stresses and age. In olderadults, the breakdown of bone exceeds resorption/deposition and canresult in the development of osteoporosis. Additionally, calcium isrequired for other bodily and cellular functions including vascularcontraction and vasodilation, muscle function, nerve transmission,intracellular signaling and hormonal secretion. Magnesium is needed forhundreds of biochemical reactions in the body, maintenance of normalmuscle and nerve function, a healthy immune system, and bone integrity.Magnesium is also involved with blood sugar and blood pressureregulation, energy metabolism and protein synthesis.

Maintenance treatment in a daily diet with functional food compositionsdirected to general bone health (up to 4000 IU vitamin D, 1000 mgscalcium, 100 micrograms vitamin K₂, and 320 mgs magnesium) can be usefulfor the prevention of bone loss, for example osteoporosis andosteomalacia, the prevention of disease states, for example rickets,mitigating chronic bone and joint pain, and contributing to generalhealth and wellness of the skeletal support structure.

V. Overview of the Functional Nutrition Compositions for CardiovascularHealth

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, provide nutritional supplements and anincrease in general health and well-being. The functional foodcomposition contains an edible or potable substance that is encapsulatedin an edible membrane, and further contains bioflavonoids, carotenes andessential fatty acid compounds supplementing a normal diet. Thefunctional food compositions described herein provide a convenient andimproved way for individuals to consume bioflavonoids, carotenes andessential fatty acid compounds in combinations and/or sufficientquantities needed to supplement normal diet, promote normal growth anddevelopment, treat disease conditions particularly related tocardiovascular health, and increase general health and well-beingrelated thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits arise from providing an importantnutritive food source, vitamins and supplements and/or compounds such asbioflavonoids, carotenes and essential fatty acid compounds thatgenerally or specifically contribute to increased health. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases or disorders. This health improvement benefitcan be provided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood composition is gained. However, delivery systems for somebioavailable compounds, including those important for supplementing adiet, can reduce the viability of the compounds, resulting in suboptimalquantities of these compounds being made available to the consumer for aparticular food composition. Often, the delivery system for anutritional supplement is in a form insufficient to promote compliancein a particular consumer group (e.g., elderly, infirm, children andyoung adults), such as being in a large pill form, powder form withlittle gustatory appeal, or poor tasting liquids.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofbioflavonoids, carotenes and essential fatty acid compounds useful to aconsumer. Within these compositions, the bioflavonoids, carotenes andessential fatty acid compounds can be compartmentalized within theedible or potable substance, the encapsulating membrane, or both. Uponmastication and ingestion, the bioflavonoids, carotenes and essentialfatty acid are released from the functional food composition to providean immediately available nutrition and edible source. The functionalfood compositions can thus be designed to have one or morebioflavonoids, carotenes and essential fatty acid in an effectivecombination and concentration desirable for the specific needs of theconsumer or patient, for example, the elderly, adult and childrenconsumers, and medical patients.

The functional food compositions described herein are designed toprovide bioflavonoids, carotenes and essential fatty acid compounds inbiologically effective quantities for promoting cardiovascular healthsuperior to commonly used products. The compositions are particularlywell-suited for providing a larger active ingredient load as well asbeing amenable for controlling the actual portion size for an intendedhealth benefit. Functional food compositions as described herein canprovide up to and above several times the suggested minimum dosages in asample serving, or provide combinations of bioflavonoids, carotenes andessential fatty acids, nutraceuticals and supplements up to and aboveseveral times the suggested minimum dosages in a single serving that isboth convenient and appetizing. A functional food delivering acombination of cardiovascular health compounds in a single servingcomposition can result in the cessation or mitigation of a multitude ofcardiac health related conditions and diseases (e.g., high cholesterol,high blood pressure, etc.), supplement dietary imbalance, and promotecompliance in the daily consumption of these and other health promotingcompounds. In addition, a general state of health and wellness canresult from a healthy diet supplemented with these and other healthpromoting compounds.

Population segments that may find useful a bioflavonoid, carotene andessential fatty acid functional food composition as described hereininclude the elderly, adults, hospital patients, those withcardiovascular disease, and those at risk for cardiovascular disease.

Consumers and patients can become noncompliant for daily intake ofcardiovascular health compounds depending on the delivery form of thecomposition. For example, some cardiovascular health compounds are inpill form with a flavor, texture and overall size (e.g., omega-3 andomega-6 fatty acids) that often results in reluctance to consume on ascheduled or daily basis. Therefore, a functional food as describedherein that delivers a daily concentration of cardiovascular healthcompounds can overcome non-compliance.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of cardiovascular healthcompounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc., inaddition to bioflavonoids, carotenes and essential fatty acid compounds,by encapsulating the substance within edible or biodegradable membranes,for which the membranes provide barriers to oxygen and oxygendegradation, diffusion, etc. The double bond(s) found within essentialfatty acid compounds are particularly susceptible to oxidativedegradation, and thus it is desirable to ensure protection againstoxygen. The edible membranes of these compositions can be formed fromvarious natural polymeric substances that allow the compositions to beeasily transported and consumed by a consumer.

Various bioflavonoids, carotenes and essential fatty acid compounds,supplements, and nutraceuticals can be included in the functional foodcompositions described herein in quantities sufficient to correlate withrecommended daily allowances, for the maintenance of cardiovascularhealth, prevention of cardiovascular diseases and beneficialsupplementation to normal dietary intake.

Lower rates of cardiovascular disease are attributed in part to theso-called Mediterranean diet, which is rich in plant derived bioactivephytochemicals. Lycopene is a natural carotene found in tomato, anessential component of the Mediterranean diet, and functions at least asan antioxidant scavenger. Nitric oxide and reactive oxygen species (ROS)including superoxide anion and hydrogen peroxide are highly reactiveoxidant molecules produced by the human body through normal metabolismand diet, and may play a role in certain diseases includingcardiovascular diseases. Antioxidants are protective compounds thatinactivate ROS and delay or prevent oxidative damage. Lycopene, is oneof the most potent antioxidants, with activity twice as high as that ofβ-carotene and tenfold higher than α-tocopherol. The oxidization of lowdensity lipoprotein (“bad cholesterol”) is thought to be the primarystep leading to its interaction with macrophages inside the arterialwall and the formation of atherosclerotic plaque. Therefore higherlevels of blood antioxidants are thought to contribute to mitigating thedegree of low density lipoprotein oxidation and plaque formation.

Medical investigations provide that regular consumption offlavonoid-containing foods also can reduce the risk of cardiovasculardiseases, providing direct evidence for the potential cardiovascularbenefits. While bioflavonoids are ubiquitous in plants, cocoa (Theobromacacao) and tea (Camellia sinensis) have been found to be particularlyrich in a sub-class of flavonoids known as flavanols. A number of humandietary intervention trials with flavanol-containing cocoa and teaproducts have demonstrated improvements in systemic function as well asregulation in blood pressure. Flavanols are also found in fruits andvegetables and are linked to certain health benefits linked to coronaryheart disease and stroke. As with lycopene and other carotenes,flavanols are thought to take part in mechanisms such as nitric oxideand antioxidant, anti-inflammatory, and antiplatelet effects to improveendothelial function, lipid levels, blood pressure and insulinresistance, particularly with respect to preventing the oxidization oflow density lipoprotein.

Generally, essential fatty acids as used herein can be considered assupplementing naturally obtained essential fatty acids in food.Essential fatty acids (DHA, in particular) are consumed as part of ahealthy diet in order to maintain and promote the treatment and/orprevention of cardiovascular disease and related disorders and events,such as high blood pressure, high cholesterol, the onset ofarthrosclerosis, heart attack and stroke. Essential fatty acids are alsoimportant for the maintenance of organ systems including eyes, nerves,brain, etc. Essential fatty acids can also add to a higher quality orperceived quality of the health state of the end user, as somecorrelations have been identified with decrease in cancer risk,effectiveness against arthritis, dementia and depression.

The functional food compositions with bioflavonoids, carotenes andessential fatty acid compounds described herein include, but are notlimited to, bioavailable forms of bioflavonoids, carotenes and essentialfatty acid compounds, bioactive derivatives thereof, salts thereof, andbioactive metabolic intermediates.

If desired, dietary fibers can also be incorporated within thefunctional food composition as described herein. Dietary fiber is theedible part of plants or analogous carbohydrates that are resistant todigestion and absorption in the human small intestine, with complete orpartial fermentation in the large intestine. Dietary fiber includespolysaccharides, oligosaccharides, lignin, and associated plantsubstances. Dietary fibers promote beneficial physiologic effectsincluding laxation, and/or constipation relief, and/or blood cholesterolattenuation, and/or blood glucose attenuation. Dietary fibers alsoenhance a satiety effect, wherein food portions can become effectivelysmaller while maintaining a feeling of fullness after a meal.

Other compounds can be used exclusively or in combination withbioflavonoids, carotenes and essential fatty acid compounds of thefunctional food compositions described herein. Nutraceuticals aregenerally thought of as food or food product that reportedly provideshealth and medical benefits, including the prevention and treatment ofdisease, and can be defined as a product isolated or purified from foodsthat is generally sold in medicinal forms not usually associated withfood. A nutraceutical may have a physiological benefit or provideprotection against chronic disease. Such nutraceutical products mayrange from isolated nutrients, vitamins and minerals, other dietarysupplements, and herbal products. With recent developments incellular-level nutraceutical agents, researchers, and medicalpractitioners are developing templates for integrating and assessinginformation from clinical studies on complementary and alternativetherapies into responsible medical practice.

Cardiovascular Health Compositions with Bioflavonoids, Carotenes andEssential Fatty Acid Compounds

In general antioxidants contemplated for use for the functional foodcomposition as described herein can include, without limitationcarotenes, bioflavonoids (flavonoids, isoflavones, neoflavonals),tocopherol, tocotrienol, lipoic acid, melatonin, superoxide dismutase,coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, seleniumand ascorbic acid. Carotenes contemplated for use as membrane particlesinclude α-carotene, β-carotene, γ-carotene, δ-carotene, ε-carotene,lycopene, cryptoxanthin, lutein, zeaxathin, apocarotenal astaxanthin,canthaxanthin, lutein/lutein esters, etc. If desired, the amount ofcarotene in the functional food composition serving as described hereincan be up to about 1 milligram (mg), up to about 5 mg, up to about 10mg, up to about 15 mg, up to about 20 mg, up to about 25 mg, up to about30 mg, up to about 35 mg, up to about 35 mg, up to about 40 mg, up toabout 45 mg, up to about 50 mg, up to about 60 mg, up to about 70 mg, upto about 80 mg, up to about 90 mg, up to about 100 mg. Bioflavonoidsused for the functional food composition described herein includeesveratrol, quercetin, rutin, catechin, epichatechins,proanthocyanidins, and combinations thereof. Bioflavonoids can bederived from various plants including, for example, Camellia sinensis,Theobroma cacao (cocoa flavanols) and species, varieties, cultivars,thereof. Bioflavonoids can also be derived from or found in variousplant extracts including, but not limited to, acai berry extract,raspberry extract, cranberry extract, pomegranate extract, plum extract,cherry extract, rosemary extract, etc. Isoflavones are used as membraneparticles, including, but not limited to, genistein, daidzein, biochaninA, and formononetin. If desired, the amount of bioflavonoid in thefunctional food composition serving as described herein can be up toabout up to about 50 mg, up to about 100 mg, up to about 150 mg, up toabout 200 mg, up to about 250 mg, up to about 300 mg, up to about 350mg, up to about 400 mg, up to about 450 mg, up to about 500 mg, up toabout 600 mg, up to about 700 mg, up to about 800 mg, up to about 900mg, up to about 1000 mg.

Essential fatty acids for the functional food composition as describedherein can include, without limitation, all-cis-7,10,13-hexadecatrienoicacid (HTA), all-cis-9,12,15-octadecatrienoic acid (ALA),all-cis-6,9,12,15-octadecatetraenoic acid,all-cis-11,14,17-eicosatrienoic acid (ETE),all-cis-8,11,14,17-eicosatetraenoic acid (ETA),all-cis-5,8,11,14,17-eicosapentaenoic acid (EPA),all-cis-6,9,12,15,18-heneicosapentaenoic acid (HPA),all-cis-7,10,13,16,19-docosapentaenoic acid(DPA),all-cis-4,7,10,13,16,19-docosahexaenoic acid (DHA),all-cis-9,12,15,18,21-tetracosapentaenoic acid,all-cis-6,9,12,15,18,21-tetracosahexaenoic acid (nisinic acid). Ifdesired, the amount of essential fatty acids in the functional foodcomposition as described herein can be up to about 3 grams. Inparticular, essential fatty acid ETA can be provided in the compositionat about 50 milligrams (mgs), up to about 100 mgs, up to about 200 mgs,up to about 300 mgs, up to about 400 mgs, up to about 500 mgs, up toabout 600 mgs, up to about 700 mgs, up to about 800 mgs, up to about 900mgs, up to about 1000 mgs, up to about 1200 mgs, up to about 1400 mgs,up to about 1600 mgs, up to about 1800 mgs, up to about 2000 mgs, up toabout 2500 mgs, up to about 3000 mgs. If desired, the amount ofessential fatty acids in the functional food composition as describedherein can be up to about 3 grams. In particular, essential fatty acidDHA can be provided in the composition at about 50 milligrams (mgs), upto about 100 mgs, up to about 200 mgs, up to about 300 mgs, up to about400 mgs, up to about 500 mgs, up to about 600 mgs, up to about 700 mgs,up to about 800 mgs, up to about 900 mgs, up to about 1000 mgs, up toabout 1200 mgs, up to about 1400 mgs, up to about 1600 mgs, up to about1800 mgs, up to about 2000 mgs, up to about 2500 mgs, up to about 3000mgs.

Uses of Edible Cardiovascular Health Compositions

Functional food compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state, as well asprovide a source of bioflavonoids, carotenes and essential fatty acidcompounds for cardiovascular health, treatment and maintenance. Thesebenefits can be provided to a consumer when new ingredients or more ofan existing ingredient are added to a food so that an added healthbenefit from the food product is gained.

Supplementing a diet with bioflavonoids, carotenes and essential fattyacids deliverable in the functional foods as described herein is usefulfor prevention and treatment of a variety of conditions and diseasesrelated developmental disorders, particularly those related tocardiovascular disease, including high blood cholesterol, high bloodpressure, arterial plaque development and atherosclerosis, for themitigation of cardiovascular events including stroke and heart attack,as well as for general health maintenance.

The functional food compositions as described herein increase theeffective delivered concentration of such useful bioflavonoids,carotenes and essential fatty acid compounds, and can be formulated fordaily dietary supplements, preventative treatment or for clinicalapplications treating systemic or chronic disease states and disorders.

VI. Overview of the Functional Nutrition Compositions for Joint andCartilage Health

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, promote joint and cartilage structurehealth and well-being and maintenance of cartilage structure. Thefunctional food composition contains an edible or potable substance thatis encapsulated in an edible membrane, and further contains compoundsfor joint and cartilage structure health. The functional foodcompositions described herein provide a convenient and improved way forindividuals to consume joint and cartilage structure health compounds incombinations and/or sufficient quantities needed to promote joint andcartilage structure health and well-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits arise from providing an importantnutritive food source, vitamins and supplements and/or compounds thatgenerally or specifically contribute to increased health. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases or disorders. This health improvement benefitcan be provided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood composition is gained. However, delivery systems for somebioavailable compounds, including those important for joint andcartilage health, can reduce the viability of the compounds, resultingin suboptimal quantities of these compounds being made available to theconsumer for a particular food composition.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofcompounds useful for joint and cartilage health and maintenanceavailable to a consumer. Within these compositions, the joint andcartilage health compounds can be compartmentalized within the edible orpotable substance, the encapsulating membrane, or both. Upon masticationand ingestion, the joint and cartilage health compounds are releasedfrom the functional food composition to provide an immediately availablenutrition source. The functional food compositions can thus be designedto have one or more joint and cartilage health compounds in an effectivecombination and concentration desirable for the specific needs of theconsumer or patient, for example, elderly, children, and medicalpatients.

The functional food compositions described herein are designed toprovide joint and cartilage health compounds in biologically effectivequantities superior to commonly used products. The compositions areparticularly well-suited for providing a larger active ingredient loadas well as being amenable for controlling the actual portion size for anintended health benefit. Functional food compositions as describedherein can provide up to and above several times the suggested minimumdosages in a simple serving, or provide combinations of joint andcartilage health compounds, vitamins and supplements up to and aboveseveral times the suggested minimum dosages in a single serving that isboth convenient and appetizing. A functional food delivering acombination of vitamins, supplements and joint and cartilage healthcompounds in a single product can benefit from a resulting synergisticinteraction, as has been identified, for example, in patients andconsumers suffering joint pain from a variety of causes, includingarthritic diseases such as osteoarthritis and rheumatoid arthritis.Apart from joint pain, insufficient maintenance of joint cartilage canresult in immobility and joint disfigurement.

Population segments that may find useful a functional food joint andcartilage health composition as described herein include the elderly,athletes, laborers, and patients having undergone reparative surgery,reconstructive surgery and the like. These consumers and patients canbecome susceptible to arthritis, osteoarthritis, chronic pain, reductionin joint mobility and function, joint effusion, joint erosion, jointinflammation, synovitis, rheumatoid arthritis, psoriatic arthritis,osteoarthrosis, and acute inflammation.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc. and jointand cartilage health compounds, by encapsulating the substance withinedible membranes, for which the membranes provide barriers to oxygen,diffusion, etc. The edible membranes of these compositions can be formedfrom various natural polymeric substances that allow the compositions tobe easily transported and consumed by a consumer.

Various supplements, nutraceuticals and products for joint and cartilagehealth also can be included in the functional food compositionsdescribed herein in quantities sufficient to correlate with increasedstate of health and beneficial treatment of joint and cartilagedisorders, in a form that provides a tasty and delicious gustatoryexperience. The functional food compositions for use in joint andcartilage health and nutrition described herein include, but are notlimited to, bioavailable forms of collagen, glucosamine, hyaluronicacid, and chondroitin, other compounds that act as catalysts or supplyraw materials for bone and connective tissue synthesis(S-adenosylmethionione (SAM), methylsulfonylmethane (MSM)), vitamins andminerals, anti-oxidants, anti-inflammatory compounds, and essentialfatty acids.

Functional nutrition compounds specific for joint and cartilage healthhave been correlated with disease prevention and general health andwellbeing. For example, glucosamine and chondroitin have been used forthe therapeutic treatment of osteoarthritis/arthritis, joint painmitigation, and preventative health maintenance of joint cartilage.Additionally, compounds including collagen and hyaluronic acid have beenused to some effectiveness in the treatment of joint and cartilagedisease and disorders, or as a maintenance supplement for joint andcartilage health.

Glucosamine (glucosamine sulfate, glucosamine hydrochloride, and/orN-acetylglucosamine) is a nitrogen containing sugar with important rolesin biochemical pathways for the production of glycosolated protein,lipids, and all nitrogen containing sugars. Since glucosamine is aprecursor for glycosaminoglycans, a major component of joint cartilage,glucosamine supplements are thought to contribute to the development andmaintenance of cartilage structure, and thus the alleviation ofarthritis.

Chondroitin sulfate likely results in anti-inflammatory activity throughthe promotion or synthesis of beneficial metabolites (proteoglycans andhyaluronic acid), and the attenuation of synthesis of harmfulcatabolites that further inhibit the synthesis of proteolytic enzymes,nitric oxide, and other substances that contribute to damage ofcartilage matrix and cause death of articular chondrocytes. Therefore,treatment of arthritis and other cartilage and joint conditions withchondroitin sulfate is based on the belief that osteoarthritis isassociated with a local deficiency or degradation of natural substances,including internal chondroitin sulfate.

Generally, glucosamine and/or chondroitin and/or metabolic derivativesand/or complexes thereof, can be incorporated into the membrane and/oredible or potable substance. Some servings of the functional foodcomposition herein provide up to about up to about 2000 mgs total of oneor more of glucosamine, chondroitin, derivatives thereof, and/orcomplexes thereof.

Collagen is a group of naturally occurring proteins found in the skinand connective tissues of animals, making up about one third of thewhole-body protein content. Collagen occurs in many places throughoutthe body and comprises the main component of connective tissue. Manytypes of collagen are known, the most common being collagen I (skin,tendon, vascular ligature, organs, the main component of the organicpart of bone), collagen II (main component of cartilage), collagen III(main component of reticulate fibers and commonly found alongside typeI), collagen IV (forming the bases of cell basement membrane), andcollagen V (cell surfaces, hair and placenta). Collagen-related diseasesmost commonly arise from genetic defects or nutritional deficienciesthat affect the biosynthesis, assembly, postranslational modification,secretion, or other processes involved in normal collagen production.Hydrolyzed and non-hydrolyzed type II collagen, often in combinationwith other joint and cartilage health compounds, can be used for jointpain relief and treatment of arthritis and other joint conditions anddiseases.

Hyaluronic acid is a polymer of disaccharides composed of glucuronicacid and N-acetylglucosamine, and is a major component of synovialfluid. Hyaluronic acid functions to increase the viscosity of the fluidand increase effectiveness of lubrication properties. Hyaluronan is alsoan important component of articular cartilage where it is present as acoat around each chondrocyte cell. Since hyaluronic acid is a majorcomponent of joint cartilage, hyaluronic acid supplements are thought tocontribute to the development and maintenance of cartilage structure,and thus the alleviation of arthritis and other joint and cartilagedisorders.

In general, a reduction in pain and discomfort, improvement in qualityof life and ability to perform activities of daily living, andmeasurable differences in concentration of metabolites or cartilagedensity are all indicators of the health benefits when consuming thefunctional food compositions for joint and cartilage health describedherein.

Joint and Cartilage Health Compositions

Compounds in concentration and/or type contained within the functionalfood compositions included herein may be used in addition to naturallevels of joint and cartilage health compounds in the food source.

Generally, chondroitin and bioavailable and bioactive metabolicderivatives and/or complexes can be included in membranes encapsulatingan edible or potable substance and/or within the edible or potablesubstance. Chondroitin sulfate, itself metabolized from a glucosamineprecursor, is a nitrogen containing sugar composed of a chain ofalternating N-acetylgalactosamine and glucuronic acids, each potentiallysulfated at any of 3 atom positions to yield a number of chondroitinsulfate fractions (chondroitin-4-sulfate, chondroitin-6-sulfate,chondroitin-4,6-sulfate, chondroitin-2,6-sulfate). Other chondroitinforms for use in the functional food composition described hereininclude chondroitin chloride, chondroitin bromide, chondroitin sulfate,and chondroitin iodide. If desired, the amount of chondroitin providedin a joint and cartilage health functional food composition can besufficient for a recommended daily intake, for example, 200 mgs total,up to about 400 mgs total, up to about 600 mgs total, up to about 800mgs total, up to about 1000 mgs total, up to about 1200 mgs total, up toabout 1400 mgs total, up to about 1600 mgs total, up to about 1800 mgstotal, up to about 2000 mgs.

Generally, glucosamine is a nitrogen containing sugar with importantroles in biochemical pathways for the production of glycosolatedprotein, lipids, and all nitrogen containing sugars. Bioavailable andbioactive forms of glucosamine include glucosamine sulfate, glucosaminehydrochloride, and/or N-acetylglucosamine, glucosamine hydroiodide,glucosamine pyruvate, glucosamine phosphate, β-glucosamine, andα-glucosamine. If desired, the amount of glucosamine provided in a jointand cartilage health functional food composition can be sufficient for arecommended daily intake, for example, 200 mgs total, up to about 400mgs total, up to about 600 mgs total, up to about 800 mgs total, up toabout 1000 mgs total, up to about 1200 mgs total, up to about 1400 mgstotal, up to about 1600 mgs total, up to about 1800 mgs total, up toabout 2000 mgs.

Generally, collagen compounds comprising type II and/or hydrolyzed typeII collagen have been shown to be most effective for treatment of jointand cartilage health. If desired, the amount of collagen provided in ajoint and cartilage health functional food composition can be sufficientfor a recommended daily intake, for example, up to 1000 mgs total, up toabout 2000 mgs total, up to about 3000 mgs total, up to about 4000 mgstotal, up to about 5000 mgs total, up to about 6000 mgs total, up toabout 7000 mgs total, up to about 8000 mgs total, up to about 9000 mgstotal, up to about 10,000 mgs.

Generally, hyaluronic compounds and/or salts, have been shown to beeffective for treating joint pain. Bioavailable forms of hyaluronic acidinclude, for example, sodium hyaluronate, potassium hyaluronate,magnesium hyaluronate and calcium hyaluronate. If desired, the amount ofhyaluronic acid provided in a joint and cartilage health functional foodcomposition can be sufficient for a recommended daily intake, forexample, up to about 10 mg, up to about 50 mgs, up to about 100 mgs, upto about 500 mgs, up to about 1000 mgs, up to about 1500 mgs, up toabout 2000 mgs, up to about 2500 mgs, up to about 3000 mgs.

Generally, other compounds and/or bioavailable metabolic derivatives caninclude vitamins (for example, vitamin A, vitamin B, vitamin C, vitaminD, vitamin E, vitamin K, etc), minerals (for example calcium, iron,copper, zinc, magnesium, manganese, phosphorus, potassium, etc.),essential fatty acids (for example, omega-3-fatty acid, omega-6-fattyacid, etc.), essential amino acids (L-histidine, L-isoleucine,L-leucine, L-lysine, L-methionine, L-phenylalanine, L-valine andL-threonine), antioxidant agents and anti-inflammatory agents.

Uses of Edible Compositions for Joint and Cartilage Health andMaintenance

Edible transport compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases. This benefit can be provided to a consumer when newingredients or more of an existing ingredient are added to a food sothat an added health benefit from the food product is gained. Joint andcartilage health compounds such as glucosamine, chondroitin, collagen,hyaluronic acid or supplements including, without limitation, vitamins,minerals, amino acids, antioxidants, anti-inflammatory agents, andessential fatty acids are useful for a variety of conditions anddiseases as well as general health maintenance. The effectiveness ofjoint and cartilage health treatment and maintenance is enhanced throughthe use of an efficient delivery system. The functional foodcompositions as described herein increase the effective deliveredconcentration of such useful joint and cartilage health compositions,and can be formulated for daily dietary supplements, preventativetreatment or for clinical applications treating systemic disease states.

Supplementing daily dietary intake with joint and cartilage healthcompounds as a functional food composition contributes to maintenance ofjoints and cartilage, an important health concern that increases withphysical stresses and age. In older adults, the breakdown of cartilageexceeds the rate of replacement. Various diseases and conditions canpresent in a consumer or patient from insufficient cartilagemaintenance, including osteoarthritis, chronic pain, reduction in jointmobility and function, joint effusion, joint erosion, jointinflammation, synovitis, rheumatoid arthritis, psoriatic arthritis,osteoarthrosis, and acute inflammation.

Maintenance treatment in a daily diet with functional food compositionsdirected to general joint and cartilage health (up to about 2000milligrams chondroitin, up to about 2000 milligrams of glucosamine, upto about 200 milligrams hyaluronic acid, and up to about 3000 milligramsof collagen) can be useful for the prevention of cartilage breakdown andloss due to aging, the prevention of disease states, for example forexample arthritis/degenerative joint disease, mitigating chronic jointpain, and contributing to general health and wellness of the cartilageand joints.

VII. Overview of the Functional Nutrition Compositions ContainingMultivitamins

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, provide nutritional supplements and anincrease in general health and well-being. The functional foodcomposition contains an edible or potable substance that is encapsulatedin an edible membrane, and further contains multivitamin compoundssupplementing a normal diet or for use with dietary imbalances. Thefunctional food compositions described herein provide a convenient andimproved way for individuals to consume multivitamin compounds incombinations and/or sufficient quantities needed to supplement normaldiet, treat dietary imbalances, and increase general health andwell-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits arise from providing an importantnutritive food source, vitamins and supplements and/or compounds thatgenerally or specifically contribute to increased health. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases or disorders. This health improvement benefitcan be provided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood composition is gained. However, delivery systems for somebioavailable compounds, including those important for supplementing adiet, can reduce the viability of the compounds, resulting in suboptimalquantities of these compounds being made available to the consumer for aparticular food composition. Often, the delivery system for anutritional supplement is in a form insufficient to promote compliancein a particular consumer group (e.g., children and young adults), suchas being in a pill form, powder form with little gustatory appeal, orpoor tasting liquids.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofmultivitamin compounds useful to a consumer. Within these compositions,the multivitamin compounds can be compartmentalized within the edible orpotable substance, the encapsulating membrane, or both. Upon masticationand ingestion, the multivitamin compounds are released from thefunctional food composition to provide an immediately availablenutrition and edible source. The functional food compositions can thusbe designed to have one or more multivitamin compounds in an effectivecombination and concentration desirable for the specific needs of theconsumer or patient, for example, the elderly, adult and childrenconsumers, and medical patients.

The functional food compositions described herein are designed toprovide multivitamin compounds in biologically effective quantitiessuperior to commonly used products. The compositions are particularlywell-suited for providing a larger active ingredient load as well asbeing amenable for controlling the actual portion size for an intendedhealth benefit. Functional food compositions as described herein canprovide up to and above several times the suggested minimum dosages in asample serving, or provide combinations of multivitamin compounds,nutraceuticals and supplements up to and above several times thesuggested minimum dosages in a single serving that is both convenientand appetizing. A functional food delivering a combination ofmultivitamins and supplements in a single serving composition can resultin the cessation or mitigation of a multitude of health relatedconditions and diseases, supplement missing or low concentrations ofvitamins and minerals in a dietary imbalance, as well as promotecompliance in the daily consumption of multivitamin supplements. Inaddition, a general state of health and wellness can result from ahealthy diet supplemented with multivitamins.

Population segments that may find useful a multivitamin composition asdescribed herein include the elderly, young adults, youths and hospitalpatients. Consumers and patients can become noncompliant for dailyintake of multivitamin supplements depending on the delivery form of themultivitamin composition. For example, some multivitamins are in pillform with a flavor, texture and overall size that often results inreluctance by children to consume. A tablet or pill structure often hasnegative associations made by children, who confuse a multivitamin pillwith a pharmacological pill. For those tablets with added sweetenersthat are designed to be playful or mimic confections, children canconfuse those multivitamin pills with candy and be in danger ofover-consumption. For multivitamins designed for adult consumption,children may mistake those multivitamins compositions with compositionsformulated for children. In these instances, children are at risk oftoxic ingestion, for example iron. Therefore, a functional food asdescribed herein that delivers a daily allowance of multivitamins canovercome non-compliance and potential for confusion with a confection,adult formulations, and/or over-consumption.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc. andmultivitamin compounds, by encapsulating the substance within edible orbiodegradable membranes, for which the membranes provide barriers tooxygen, diffusion, etc. The edible membranes of these compositions canbe formed from various natural polymeric substances that allow thecompositions to be easily transported and consumed by a consumer.

Various vitamins, supplements, and nutraceuticals can be included in thefunctional food compositions described herein in quantities sufficientto correlate with recommended daily allowances and beneficialsupplementation to normal dietary intake, in a form that provides atasty and delicious gustatory experience. The functional foodcompositions for use in multivitamin supplementation and generalnutrition described herein include, but are not limited to, bioavailableforms of vitamins, derivatives, salts thereof, and bioactive metabolicintermediates.

Generally, multivitamins as used herein can be considered as vitaminsand/or minerals taken in addition to naturally obtainedvitamins/minerals in food. Multivitamins are taken 1) to enhance thephysical well-being or state of health of the end user, 2) as a healthrelated supplement, 3) as supplements required for enhancing deficientvitamin/mineral states in the end user, and/or 4) as supplements tomitigate low concentrations or missing vitamins and minerals due todietary imbalances (e.g. “finicky” eaters, vegetarians, highly activepeople as well as those on specialized diets, sufferers of chronicillnesses such as diabetes, persons having genetic diseases, etc.).Dietary supplements can also add to a higher quality or perceivedquality of the health state of the end user.

If desired, vitamins and/or minerals that can be toxic to specificpopulation segments can be eliminated from the functional foodformulations. For example, iron toxicity is possible for young adult andchild consumers. Therefore, in these formulations it may be desirable toprovide a functional food formulation with iron fortification.

Other compounds can be used exclusively or in combination withmultivitamins functional food compositions described herein.Nutraceuticals are generally thought of as food or food product thatreportedly provides health and medical benefits, including theprevention and treatment of disease, and can be defined as a productisolated or purified from foods that is generally sold in medicinalforms not usually associated with food. A nutraceutical may have aphysiological benefit or provide protection against chronic disease.Such nutraceutical products may range from isolated nutrients, dietarysupplements, herbal products, and fiber. With recent developments incellular-level nutraceutical agents, researchers, and medicalpractitioners are developing templates for integrating and assessinginformation from clinical studies on complementary and alternativetherapies into responsible medical practice.

Multivitamin Compositions

Compounds in concentration and/or type contained within the functionalfood compositions included herein may be used in addition to naturallevels of multivitamin compounds in the food source.

Generally, multivitamins and bioavailable and bioactive metabolicderivatives and/or complexes can be included in membranes encapsulatingan edible or potable substance and/or within the edible or potablesubstance. Concentrated, isolated and combinations of compounds usefulas multivitamins are commercially available. Generally, vitamins,minerals and other supplements that can be used in the multivitaminfunctional food can be, without limitation, ascorbic acid (vitamin C),vitamin B₁₂, biotin, fat soluble vitamins, folic acid, HCA(hydroxycitric acid), inositol, pyruvate, mineral ascorbates, mixedtocopherols, niacin (vitamin B₃), orotic acid, PABA (para-aminobenzoicacid), pantothenates, pantothenic acid (vitamin B₅), pyridoxinehydrochloride (vitamin B₆), riboflavin (Vitamin B₂), synthetic vitamins,thiamine (vitamin B₁, tocotrienols, vitamin A, vitamin D₃, vitamin E,vitamin F (linoleic acid (LA) and alpha-linoleic acid (LNA)), vitaminK₁, vitamin K₂, vitamin oils, vitamin premixes, vitamin-mineralpremixes, water soluble vitamins, arsenic, boron, calcium, chloride,chromium, cobalt, copper, fluorine, iodine, iron, magnesium, manganese,molybdenum, nickel, phosphorous, potassium, selenium, silicon, sodium,strontium, sulfur, vanadium, zinc, combinations thereof, etc. Ifdesired, the amount of vitamins, minerals and/or other supplementsprovided in a multivitamin functional food composition sufficient for aneffective daily intake can be, for example, up to 20% of recommendeddaily allowance (RDA), up to 30% RDA, up to 40% RDA, up to 50% RDA, upto 60% RDA, up to 70% RDA, up to 80% RDA, up to 90% RDA, up to 100% RDA,up to 500% RDA, up to 1000% RDA, up to 2000% RDA, up to 3000% RDA, up to4000% RDA, up to 5000% RDA.

If desired, enzymes and amino acids can be included in the functionalfood as described herein, and include, but are not limited to, alphagalactosidase, amylase, bromelain, cellulase, papain, peptidase,protease, proteolytic enzymes, superoxide dismutase, trypsin, betaine,casein, glutamic Acid, L-alanine, L-arginine, L-cysteine, L-glutamine,L-glycine, L-isoleucine, L-leucine, L-methionine, L-ornithine,L-phenylalanine, L-proline, L-taurine, L-threonine, L-tryptophan,L-tyrosine, L-valine, N-acetly-L-cysteine, protein soluble soy, soyprotein isolates, whey protein isolates, combinations thereof, etc.

If desired, antioxidants can be included in the functional food asdescribed herein, and include, but are not limited to, carotenoids,flavonoids, isoflavones, tocopherol, tocotrienol, lipoic acid,melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid,vitamin A, chromium biotin, selenium, ascorbic acid combinationsthereof, etc. Carotenoids include include alpha-carotene, beta-carotene,cryptoxanthin, lycopene, lutein, zeaxathin, apocarotenal astaxanthin,canthaxanthin, lutein/lutein esters, combinations thereof, etc.Flavonoids include used as membrane particles include esveratrol,quercetin, rutin, catechin, proanthocyanidins, acai berry extract,raspberry extract, cranberry extract, pomegranate extract, plum extract,cherry extract, rosemary extract, combinations thereof, etc. Isoflavonesinclude genistein, daidzein, biochanin A, and formononetin, combinationsthereof, etc.

Uses of Edible Multivitamin Compositions

Functional food compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state, as well asprovide a vitamin and mineral supplementing resource in applicationswhere dietary imbalance is evident. This benefit can be provided to aconsumer when new ingredients or more of an existing ingredient areadded to a food so that an added health benefit from the food product isgained. Multivitamin compounds are useful for prevention and treatmentof a variety of conditions and diseases related to deficient vitaminand/or mineral intake, as well as general health maintenance. Thefunctional food compositions as described herein increase the effectivedelivered concentration of such useful multivitamin compositions, andcan be formulated for daily dietary supplements, preventative treatmentor for clinical applications treating systemic or chronic disease statesand disorders.

VIII. Overview of the Functional Nutrition Compositions ContainingEssential Fatty Acids

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, provide nutritional supplements and anincrease in general health and well-being. The functional foodcomposition contains an edible or potable substance that is encapsulatedin an edible membrane, and further contains essential fatty acids anddietary fiber compounds supplementing a normal diet. The functional foodcompositions described herein provide a convenient and improved way forindividuals to consume essential fatty acid compounds and optionallydietary fiber in combinations and/or sufficient quantities needed tosupplement normal diet, promote normal growth and development, treatdisease conditions, and increase general health and well-being relatedthereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits arise from providing an importantnutritive food source, vitamins and supplements and/or compounds such asessential fatty acids and dietary fiber that generally or specificallycontribute to increased health. A higher degree of health assists in theprevention, management and treatment of acute or chronic diseases ordisorders. This health improvement benefit can be provided to a consumerwhen additional ingredients or more of an existing ingredient are addedto a food so that the benefit from the food composition is gained.However, delivery systems for some bioavailable compounds, includingthose important for supplementing a diet, can reduce the viability ofthe compounds, resulting in suboptimal quantities of these compoundsbeing made available to the consumer for a particular food composition.Often, the delivery system for a nutritional supplement is in a forminsufficient to promote compliance in a particular consumer group (e.g.,children and young adults), such as being in a large pill form, powderform with little gustatory appeal, or poor tasting liquids.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofessential fatty acid compounds and dietary fiber useful to a consumer.Within these compositions, the essential fatty acid compounds anddietary fiber can be compartmentalized within the edible or potablesubstance, the encapsulating membrane, or both. Upon mastication andingestion, the essential fatty acid compounds and optionally dietaryfiber are released from the functional food composition to provide animmediately available nutrition and edible source. The functional foodcompositions can thus be designed to have one or more essential fattyacid compounds and dietary fiber in an effective combination andconcentration desirable for the specific needs of the consumer orpatient, for example, the elderly, adult and children consumers, andmedical patients.

The functional food compositions described herein are designed toprovide essential fatty acid compounds and dietary fiber in biologicallyeffective quantities superior to commonly used products. Thecompositions are particularly well-suited for providing a larger activeingredient load as well as being amenable for controlling the actualportion size for an intended health benefit. Functional foodcompositions as described herein can provide up to and above severaltimes the suggested minimum dosages in a sample serving, or providecombinations of essential fatty acid compounds and dietary fiber,nutraceuticals and supplements up to and above several times thesuggested minimum dosages in a single serving that is both convenientand appetizing. A functional food delivering a combination of essentialfatty acid compounds, dietary fiber and supplements in a single servingcomposition can result in the cessation or mitigation of a multitude ofhealth related conditions and diseases, supplement dietary imbalance,promote normal development of organ systems such as nerves, brain andeyes, treat disease (e.g., coronary disease) and related disorders(e.g., high cholesterol, high blood pressure, etc.) and promotecompliance in the daily consumption of these and other health promotingcompounds. In addition, a general state of health and wellness canresult from a healthy diet supplemented with these and other healthpromoting compounds.

Population segments that may find useful an essential fatty acid anddietary fiber functional food composition as described herein includethe elderly, adults, young adults, youths and hospital patients.Consumers and patients can become noncompliant for daily intake ofessential fatty acids and dietary fiber compounds depending on thedelivery form of the composition. For example, some essential fattyacids are in pill form with a flavor, texture and overall size thatoften results in reluctance by children to consume. A tablet or pillstructure often has negative associations made by children, who confusea supplement pills with a pharmacological pill. Therefore, a functionalfood as described herein that delivers a daily allowance of essentialfatty acids and dietary fiber can overcome non-compliance.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc. andessential fatty acid compounds and dietary fiber, by encapsulating thesubstance within edible or biodegradable membranes, for which themembranes provide barriers to oxygen and oxygen degradation, diffusion,etc. The double bond(s) found within essential fatty acid compounds areparticularly susceptible to oxidative degradation, and thus it isdesirable to ensure protection against oxygen. The edible membranes ofthese compositions can be formed from various natural polymericsubstances that allow the compositions to be easily transported andconsumed by a consumer.

Various essential fatty acid compounds, dietary fiber, supplements, andnutraceuticals can be included in the functional food compositionsdescribed herein in quantities sufficient to correlate with recommendeddaily allowances, promotion of organ system development, and beneficialsupplementation to normal dietary intake, in a form that provides atasty and delicious gustatory experience. The functional foodcompositions for use with essential fatty acid and dietary fibercompounds described herein include, but are not limited to, bioavailableforms of essential fatty acids and dietary fibers, bioactive derivativesthereof, salts thereof, and bioactive metabolic intermediates.

Generally, essential fatty acids and dietary fiber as used herein can beconsidered supplementing naturally obtained essential fatty acids anddietary fiber in food. Essential fatty acids are consumed as part of ahealthy diet in order to maintain and promote the development of certainorgan systems including eyes, nerves, brain, etc. (DHA, in particular).The fatty acid compounds are also used for the treatment and/orprevention of cardiovascular disease and related disorders and events,such as high blood pressure, high cholesterol, the onset ofarthrosclerosis, heart attack and stroke. Essential fatty acids can alsoadd to a higher quality or perceived quality of the health state of theend user, as some correlations have been identified with decrease incancer risk, effectiveness against arthritis, dementia and depression.

If desired, dietary fibers can also be incorporated within thefunctional food composition as described herein. Dietary fiber is theedible parts of plants or analogous carbohydrates that are resistant todigestion and absorption in the human small intestine, with complete orpartial fermentation in the large intestine. Dietary fiber includespolysaccharides, oligosaccharides, lignin, and associated plantsubstances. Dietary fibers promote beneficial physiologic effectsincluding laxation, and/or constipation relief, and/or blood cholesterolattenuation, and/or blood glucose attenuation. Dietary fibers alsoenhance a satiety effect, wherein food portions can become effectivelysmaller while maintaining a feeling of fullness after a meal.

Other compounds can be used exclusively or in combination with essentialfatty acids and dietary fiber functional food compositions describedherein. Nutraceuticals are generally thought of as food or food productthat reportedly provides health and medical benefits, including theprevention and treatment of disease, and can be defined as a productisolated or purified from foods that is generally sold in medicinalforms not usually associated with food. A nutraceutical may have aphysiological benefit or provide protection against chronic disease.Such nutraceutical products may range from isolated nutrients, vitaminsand minerals, other dietary supplements, and herbal products. Withrecent developments in cellular-level nutraceutical agents, researchers,and medical practitioners are developing templates for integrating andassessing information from clinical studies on complementary andalternative therapies into responsible medical practice.

Essential Fatty Acid and Dietary Fiber Compositions

Essential fatty acids for the functional food composition as describedherein can include, without limitation, all-cis-7,10,13-hexadecatrienoicacid (HTA), all-cis-9,12,15-octadecatrienoic acid (ALA),all-cis-6,9,12,15-octadecatetraenoic acid,all-cis-11,14,17-eicosatrienoic acid (ETE),all-cis-8,11,14,17-eicosatetraenoic acid (ETA),all-cis-5,8,11,14,17-eicosapentaenoic acid (EPA),all-cis-6,9,12,15,18-heneicosapentaenoic acid (HPA),all-cis-7,10,13,16,19-docosapentaenoic acid(DPA),all-cis-4,7,10,13,16,19-docosahexaenoic acid (DHA),all-cis-9,12,15,18,21-tetracosapentaenoic acid,all-cis-6,9,12,15,18,21-tetracosahexaenoic acid (nisinic acid). Ifdesired, the amount of essential fatty acids in the functional foodcomposition as described herein can be up to about 3 grams. Inparticular, essential fatty acid ETA can be provided in the compositionat about 50 milligrams (mgs), up to about 100 mgs, up to about 200 mgs,up to about 300 mgs, up to about 400 mgs, up to about 500 mgs, up toabout 600 mgs, up to about 700 mgs, up to about 800 mgs, up to about 900mgs, up to about 1000 mgs, up to about 1200 mgs, up to about 1400 mgs,up to about 1600 mgs, up to about 1800 mgs, up to about 2000 mgs, up toabout 2500 mgs, up to about 3000 mgs. If desired, the amount ofessential fatty acids in the functional food composition as describedherein can be up to about 3 grams. In particular, essential fatty acidDHA can be provided in the composition at about 50 milligrams (mgs), upto about 100 mgs, up to about 200 mgs, up to about 300 mgs, up to about400 mgs, up to about 500 mgs, up to about 600 mgs, up to about 700 mgs,up to about 800 mgs, up to about 900 mgs, up to about 1000 mgs, up toabout 1200 mgs, up to about 1400 mgs, up to about 1600 mgs, up to about1800 mgs, up to about 2000 mgs, up to about 2500 mgs, up to about 3000mgs.

Dietary fibers for the functional food composition as described hereincan include, both soluble and insoluble dietary fibers, including, butnot limited to, galacto-oligosaccharides, inulin and oligofructose(fructo-oligosaccharide), isomalto-oligosaccharides, lactulose,lactosucrose, transgalacto-oligosaccharides, soybean oligosaccharides,tagatose, xylo-oligosaccharides, and combinations thereof. The dietaryfiber can be an oligosaccharide fructan including, but not limited to,fructo-oligosaccharide and derivatives thereof of inulin(poly-D-fructose, itself derived from various plant products includingbananas, onions, chicory root, garlic, asparagus, barley, wheat, jicama,leeks, etc.) or from transfructosylation action of a β-fructosidase asused, for example, by Aspergillus sp. metabolically active on sucrose.Dietary fibers can be derived from plants and plant products including,but not limited to, artichoke, dandelion greens, bran, flour, legumes,oats, citrus fruits, apples, and root vegetables, cane sugar, etc. Ifdesired, the amount of total dietary fiber per function food serving canbe less than about 1 gram, less than about 2.5 grams, less than about 5grams, less than about 7.5 grams, less than about 10 grams, less thanabout 12.5 grams, less than about 15 grams, less than about 17.5 grams,less than about 20 grams.

Uses of Edible Essential Fatty Acid and Dietary Fiber Compositions

Functional food compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state, as well asprovide a source of essential fatty acids to promote eye, brain andnerve development, and dietary fiber to gastrointestinal and cardiachealth. These benefits can be provided to a consumer when newingredients or more of an existing ingredient are added to a food sothat an added health benefit from the food product is gained.

Supplementing a diet with essential fatty acids deliverable in thefunctional foods as described herein is useful for prevention andtreatment of a variety of conditions and diseases related developmentaldisorders (particularly those related to eyes, brain and the nervoussystem), immunity (arthritis), cardiovascular disease (high bloodcholesterol, high blood pressure, plaque development), and psychologicaldisorders (depression and dementia), as well as for general healthmaintenance.

Supplementing a diet with essential fatty acids deliverable in thefunctional foods as described herein is useful for prevention andtreatment of a variety of conditions and diseases. Particularapplications include a scheduled dietary fiber intake for prevention ofconstipation, improvement of gastrointestinal health, a diet aid for usein weight management, reduction in risk of coronary diseases, coloncancer and diabetes.

The functional food compositions as described herein increase theeffective delivered concentration of such useful essential fatty acidsand dietary fiber compositions, and can be formulated for daily dietarysupplements, preventative treatment or for clinical applicationstreating systemic or chronic disease states and disorders.

IX. Overview of the Branched Chain Amino Acid Functional FoodCompositions

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, can increase the general healthwell-being of the consumer. The functional food composition describedherein contains an edible or potable substance that is encapsulated inan edible membrane, and further contains a branched chain amino acid(“BCAA”), supplementing the essential amino acid concentration of anormal diet. The functional food compositions described herein provide aconvenient and improved way for individuals to consume BCAAs incombinations and/or sufficient quantities needed to supplement normaldiet to treat unhealthy bodily conditions, disease and injury, andincrease general health and well-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, maintenance andpromotion of good health, disease prevention, etc. Some benefits arisefrom providing an important nutritive food source, vitamins andsupplements and/or compounds such as BCAAs that generally orspecifically contribute to increased health and wellness. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases, systemic disorders, trauma and surgery. Thishealth and wellness improvement or benefit can be provided to a consumerwhen additional ingredients or more of an existing ingredient are addedto a food so that the benefit from the food composition is gained.However, delivery systems for some bioavailable compounds, includingthose important for supplementing a diet, can reduce the viability ofthe compounds, resulting in suboptimal quantities of these compoundsbeing made available to the consumer for a particular food composition.Often, the delivery system for a nutritional supplement is in a forminsufficient to promote compliance in a particular consumer group (e.g.,elderly, infirm, children and young adults), because the delivery systemis in a large pill form, powder form with little gustatory appeal, orpoor tasting liquids.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofBCAA containing compounds useful to a consumer. Within thesecompositions, the BCAAs can be compartmentalized within the edible orpotable substance, the encapsulating membrane, or both. Upon masticationand ingestion, the BCAAs are released from the functional foodcomposition to provide an immediately available nutrition and edibleantioxidant source. The functional food compositions can thus bedesigned to have one or more BCAAs in an effective combination andconcentration desirable for the specific needs of the consumer orpatient, for example, the elderly, adult and children consumers, andmedical patients.

The functional food compositions described herein are designed toprovide BCAAs in biologically effective quantities for promoting generalhealth and well-being and muscle mass retention or development inconcentrations superior to commonly used products. The compositions areparticularly well-suited for providing a larger active ingredient loadas well as being amenable for controlling the actual portion size for anintended health benefit. Functional food compositions as describedherein can provide up to and above several times the suggested minimumdosages in a sample serving, or provide desired combinations of BCAAs,nutraceuticals and supplements up to and above several times thesuggested minimum dosages in a single serving that is both convenientand appetizing. A functional food delivering BCAAs in a single servingcomposition can result in the cessation or mitigation of a multitude ofconditions and diseases resulting in loss of muscle mass. The functionalfood described herein can also supplement dietary imbalance and promoteuser compliance in the daily consumption of these and other healthpromoting compounds for those desiring to supplement muscle maintenanceor development and growth of muscle mass. In addition, a generalmaintenance state of health and wellness can result from a healthy dietsupplemented with these and other functional foods as described herein.

Population segments that may find useful BCAAs as described hereininclude the elderly, adults, hospital patients, athletes, dieters, andthose with a variety of conditions related to trauma, nursing home andhospital care, etc. However, these consumers can become noncompliant fordaily intake of health compounds depending on the delivery form of thecomposition. For example, some health compounds are in pill form with aflavor, texture and overall size (e.g., omega-3 and omega-6 fatty acids,multivitamin supplements, etc.) that often result in reluctance toconsume on a scheduled or daily basis. Therefore, a functional food asdescribed herein that delivers a daily concentration of BCAAs canovercome non-compliance.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc., inaddition to the BCAAs, by encapsulating the substance within edible orbiodegradable membranes, for which the membranes provide barriers tooxygen and oxygen degradation, diffusion, etc. The edible membranes ofthese compositions can be formed from various natural polymericsubstances that allow the compositions to be easily transported andconsumed by a consumer.

The BCAAs are essential amino acids in humans needed for normal cellularfunction including regulation of protein synthesis and degradation.BCAAs, especially leucine, stimulate protein synthesis, inhibitproteolysis (in cell culture models and in animals), and promoteglutamine synthesis. Oxidation of BCAAs is controlled by leucinetransamination metabolites and is affected by physiological orpathological conditions such as starvation, sepsis, cancer, etc., thatresult in catabolic states depleted in alanine and glutamine.Supplementing diets with BCAAs during these catabolic states improvessynthesis of glutamine to, for example, maintain vital organ function.BCAA increases glutamine synthesis and glutamine release from muscle andelevates glutamine concentration in blood plasma. Some studies indicatethat glutamine supplementation improves recovery from infection aftervarious insults such as burns, radiation injury, severe surgical stress,sepsis, and cancer. Additionally, weight loss or wasting andmalnutrition often show in patients with prolonged catabolic stress,including, for example, post-operative and trauma care patients.However, maintenance of adequate nutrition can improve their state ofhealth.

Catabolic states can be characterized in part by increased cellularenergy consumption, and increased glutamine utilization. Increased BCAAoxidation in skeletal muscle is one of the metabolic responses thatcompensates for the increased energy expenditure and glutamineconsumption. During prolonged, severe stress, increased glutamineutilization can exceed the body's ability to synthesize glutamine, andextensive muscle glutamine depletion may result. During short termstress, intracellular muscle protein and glutamine concentrationsdecrease and intracellular muscle BCAA concentrations increase. Thenewly synthesized and mobilized glutamine can help maintain thecirculating plasma concentration and increased need for glutamine.Studies have indicated that BCAA supplementation decreases muscleprotein catabolism and amino acid efflux, and suggested that the musclecan depend in part on the BCAA supplements to satisfy its metabolicrequirements. Therefore, BCAAs as used herein in a functional foodcomposition can be any one of or a combination of L-leucine,L-isoleucine, and L-valine amino acids. Studies have shown thatL-leucine is most effective for use as a supplement. Thus it may bedesired that L-leucine is supplied preferentially, and if in combinationwith L-isoleucine and/or L-valine, L-leucine is supplied in a higherproportion to L-isoleucine and/or L-valine.

Generally, glutamine can be used in the BCAA functional food asdescribed herein as an additional supplement, as it has been shown to beuseful in treatment of injuries, trauma, burns, and treatment-relatedside effects of cancer, as well as in wound healing for postoperativepatients.

Generally, multivitamins as used herein can be considered as vitaminsand/or minerals taken in addition to naturally obtainedvitamins/minerals in food. Multivitamins are taken 1) to enhance thephysical well-being or state of health of the end user, 2) as a healthrelated supplement, 3) as supplements required for enhancing deficientvitamin/mineral states in the end user, and/or 4) as supplements tomitigate low concentrations or missing vitamins and minerals due todietary imbalances, disease states, various physiological conditions,various physical conditions, etc. Dietary supplements also may add to ahigher quality or perceived quality of the health state of the end user.

If desired, vitamins and/or minerals that can be toxic to specificpopulation segments can be eliminated from the functional foodformulations. For example, iron toxicity is possible for young adult andchild consumers. Therefore, in these formulations it may be desirable toprovide a functional food formulation without iron fortification.

Nutraceuticals are generally thought of as food or food product thatreportedly provides health and medical benefits, including theprevention and treatment of disease, and can be defined as a productisolated or purified from foods that is generally sold in medicinalforms not usually associated with food. A nutraceutical may have aphysiological benefit or provide protection against chronic disease.Such nutraceutical products may range from isolated nutrients, vitaminsand minerals, other dietary supplements, and herbal products. Withrecent developments in cellular-level nutraceutical agents, researchers,and medical practitioners are developing templates for integrating andassessing information from clinical studies on complementary andalternative therapies into responsible medical practice.

BCAA Functional Food Compositions

Generally, BCAA compositions and isolated compounds thereof,bioavailable and bioactive metabolic derivatives, and/or complexes canbe included in membranes encapsulating an edible or potable substanceand/or within the edible or potable substance. BCAA can be obtained incommercially manufactured compositions, usually in a ratio of 2 partsL-leucine:1 part L-isoleucine:1 part L-valine. Such compositionscommonly are in powdered form. Optionally, the BCAA compositioncomprises glutamine, and is often commercially identified and/or labeledas BCAA plus glutamine. Daily dosage of BCAA is dependent on theconsumer needs. For example, high muscle mass individuals and/or thoseseeking to build muscle mass may desire higher daily dosage than an“average” consumer. Other consumers such as hospital patients(post-operative patients, trauma patients, burn victims, malignantdisease sufferers, etc.) may also desire increased dosages to gain thefull health benefits of the BCAA/glutamine composition. If desired, thefunctional food compositions can provide up to about 500 milligrams(mgs), up to about 1000 mgs, up to about 2000 mgs, up to about 3000 mgs,up to about 4000 mgs, up to about 5000 mgs, up to about 6000 mgs, up toabout 7000 mgs, up to about 8000 mgs, up to about 9000 mgs, up to about10,000 mgs, up to about 12,500 mgs, up to about 15,000 mgs, up to about17,500 mgs, up to about 20,000 mgs or more of L-leucine in a singleserving size. If desired, the functional food compositions can provideup to about 500 milligrams (mgs), up to about 1000 mgs, up to about 2000mgs, up to about 3000 mgs, up to about 4000 mgs, up to about 5000 mgs,up to about 6000 mgs, up to about 7000 mgs, up to about 8000 mgs, up toabout 9000 mgs, up to about 10,000 mgs, up to about 12,500 mgs, up toabout 15,000 mgs, up to about 17,500 mgs, up to about 20,000 mgs or moreof L-isoleucine in a single serving size. If desired, the functionalfood compositions can provide up to about 500 milligrams (mgs), up toabout 1000 mgs, up to about 2000 mgs, up to about 3000 mgs, up to about4000 mgs, up to about 5000 mgs, up to about 6000 mgs, up to about 7000mgs, up to about 8000 mgs, up to about 9000 mgs, up to about 10,000 mgs,up to about 12,500 mgs, up to about 15,000 mgs, up to about 17,500 mgs,up to about 20,000 mgs or more of L-valine in a single serving size. Ifdesired, the functional food compositions can provide up to about 500milligrams (mgs), up to about 1000 mgs, up to about 2000 mgs, up toabout 3000 mgs, up to about 4000 mgs, up to about 5000 mgs, up to about6000 mgs, up to about 7000 mgs, up to about 8000 mgs, up to about 9000mgs, up to about 10,000 mgs, up to about 12,500 mgs, up to about 15,000mgs, up to about 17,500 mgs, up to about 20,000 mgs or more ofL-glutamine in a single serving size.

Generally, multivitamins and bioavailable and bioactive metabolicderivatives and/or complexes can be included in membranes encapsulatingan edible or potable substance and/or within the edible or potablesubstance. Concentrated, isolated and combinations of compounds usefulas multivitamins are commercially available. Generally, vitamins,minerals and other supplements that can be used in the multivitaminfunctional food can be, without limitation, ascorbic acid (vitamin C),vitamin B₁₂, biotin, fat soluble vitamins, folic acid, HCA(hydroxycitric acid), inositol, pyruvate, mineral ascorbates, mixedtocopherols, niacin (vitamin B₃), orotic acid, PABA (para-aminobenzoicacid), pantothenates, pantothenic acid (vitamin B₅), pyridoxinehydrochloride (vitamin B₆), riboflavin (Vitamin B₂), synthetic vitamins,thiamine (vitamin B₁, tocotrienols, vitamin A, vitamin D₃, vitamin E,vitamin F (linoleic acid (LA) and alpha-linoleic acid (LNA)), vitaminK₁, vitamin K₂, vitamin oils, vitamin premixes, vitamin-mineralpremixes, water soluble vitamins, arsenic, boron, calcium, chloride,chromium, cobalt, copper, fluorine, iodine, iron, magnesium, manganese,molybdenum, nickel, phosphorous, potassium, selenium, silicon, sodium,strontium, sulfur, vanadium, zinc, combinations thereof, etc. Ifdesired, the amount of vitamins, minerals and/or other supplementsprovided in a multivitamin functional food composition sufficient for aneffective daily intake can be, for example, up to 10% of recommendeddaily allowance (RDA), up to 20% RDA up to 30% RDA, up to 40% RDA, up to50% RDA, up to 60% RDA, up to 70% RDA, up to 80% RDA, up to 90% RDA, upto 100% RDA, up to 500% RDA, up to 1000% RDA, up to 2000% RDA, up to3000% RDA, up to 4000% RDA, up to 5000% RDA.

If desired, enzymes and amino acids can be included in the functionalfood as described herein, and include, but are not limited to, alphagalactosidase, amylase, bromelain, cellulase, papain, peptidase,protease, proteolytic enzymes, superoxide dismutase, trypsin, betaine,casein, glutamic Acid, L-alanine, L-arginine, L-cysteine, L-glutamine,L-glycine, L-histidine, L-lysine, L-methionine, L-ornithine,L-phenylalanine, L-proline, L-taurine, L-threonine, L-tryptophan,L-tyrosine, N-acetly-L-cysteine, protein soluble soy, soy proteinisolates, whey protein isolates, combinations thereof, etc.

Uses of BCAA Functional Food Compositions

Functional food compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state, as well asprovide a source of glutamine and BCAAs for the promotion andmaintenance of general health, recovery from surgical procedures, traumarecovery and treatment, wasting associated with critical/malignantdisease states, severe burns, and mitigation of disease and disordertreatment. These benefits can be provided to a consumer when newingredients or more of an existing ingredient are added to a food sothat an added health benefit from the food product is gained.

The important role that BCAA and glutamine supplements plays in musclemaintenance is recognized in the sports and athletic industry where highlevels of catabolic states are reached during strenuous activity, and sois included as a supplement used for muscle growth and maintenance forweightlifting, bodybuilding, endurance sports and other sports activity.

The functional food compositions as described herein increase theeffective delivered concentration of such useful BCAAs and glutamine,and can be formulated for daily dietary supplements, preventativetreatment and mitigation of muscle mass loss related thereto.

X. Overview of the Antioxidant Functional Food Compositions

The disclosure relates to functional food compositions that containcompounds when, upon ingestion, can increase the general health andwell-being of the consumer. The functional food composition describedherein contains an edible or potable substance that is encapsulated inan edible membrane, and further contains an edible antioxidant compoundcharacterized by an oxygen radical absorbance capacity value of at least1000 per 100 grams, supplementing the antioxidant concentration of anormal diet. The functional food compositions described herein provide aconvenient and improved way for individuals to consume antioxidants incombinations and/or sufficient quantities needed to supplement normaldiet to treat unhealthy bodily conditions and disease, and increasegeneral health and well-being related thereto.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, maintenance andpromotion of good health, disease prevention, etc. Some benefits arisefrom providing an important nutritive food source, vitamins andsupplements and/or compounds such as antioxidants that generally orspecifically contribute to increased health and wellness. A higherdegree of health assists in the prevention, management and treatment ofacute or chronic diseases or disorders. This health and wellnessimprovement or benefit can be provided to a consumer when additionalingredients or more of an existing ingredient are added to a food sothat the benefit from the food composition is gained. However, deliverysystems for some bioavailable compounds, including those important forsupplementing a diet, can reduce the viability of the compounds,resulting in suboptimal quantities of these compounds being madeavailable to the consumer for a particular food composition. Often, thedelivery system for a nutritional supplement is in a form insufficientto promote compliance in a particular consumer group (e.g., elderly,infirm, children and young adults), because the delivery system is in alarge pill form, powder form with little gustatory appeal, or poortasting liquids.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofantioxidant containing compounds useful to a consumer. Within thesecompositions, the antioxidant containing compounds can becompartmentalized within the edible or potable substance, theencapsulating membrane, or both. Upon mastication and ingestion, theantioxidants are released from the functional food composition toprovide an immediately available nutrition and edible antioxidantsource. The functional food compositions can thus be designed to haveone or more antioxidant containing compounds in an effective combinationand concentration desirable for the specific needs of the consumer orpatient, for example, the elderly, adult and children consumers, andmedical patients.

The functional food compositions described herein are designed toprovide antioxidants in biologically effective quantities for promotinggeneral health and well-being in concentrations superior to commonlyused products. The compositions are particularly well-suited forproviding a larger active ingredient load as well as being amenable forcontrolling the actual portion size for an intended health benefit.Functional food compositions as described herein can provide up to andabove several times the suggested minimum dosages in a sample serving,or provide desired combinations, of antioxidant containing compounds,nutraceuticals and supplements up to and above several times thesuggested minimum dosages in a single serving that is both convenientand appetizing. A functional food delivering a combination ofantioxidant containing compounds in a single serving composition canresult in the cessation or mitigation of a multitude of conditions anddiseases, including skin related conditions (e.g., wrinkles, dry skin,brittle nails, hair loss, skin spots, etc.), cardiovascular conditions,urinary tract conditions, etc. The functional food described herein canalso supplement dietary imbalance and promote user compliance in thedaily consumption of these and other health promoting compounds. Inaddition, a general maintenance state of health and wellness can resultfrom a healthy diet supplemented with these and other functional foodsas described herein.

Population segments that may find useful an antioxidant functional foodcomposition as described herein include the elderly, adults, hospitalpatients, those with a variety of conditions related to integument,cardiovascular health, urinary tract health, healthy brain function andmental acuity, blood sugar management, visual health, etc.

However, these consumers can become noncompliant for daily intake ofhealth compounds depending on the delivery form of the composition. Forexample, some health compounds are in pill form with a flavor, textureand overall size (e.g., omega-3 and omega-6 fatty acids, multivitaminsupplements, etc.) that often result in reluctance to consume on ascheduled or daily basis. Therefore, a functional food as describedherein that delivers a daily concentration of antioxidant containingcompounds can overcome non-compliance.

The functional food compositions described herein also enhance thestability, gustatory experience, and delivery of functional biologicallyactive compounds. The functional food compositions contain and protectingestible/edible substances, such as ice cream, yogurts, etc., inaddition to the antioxidant containing compounds, by encapsulating thesubstance within edible or biodegradable membranes, for which themembranes provide barriers to oxygen and oxygen degradation, diffusion,etc. The edible membranes of these compositions can be formed fromvarious natural polymeric substances that allow the compositions to beeasily transported and consumed by a consumer.

Generally, edible compounds that naturally contain high ORAC valuesinclude a variety of fruits and vegetables. ORAC values are expressed asthe sum of the lipid-soluble (e.g. carotenoid) and water soluble (e.g.phenolic) antioxidant fractions (i.e., “total ORAC”) of the food(fruits, vegetables, spices, etc.) and are reported in micromoles troloxequivalents (TE) per 100 gram sample compared to assessments of totalpolyphenol content in the fruit and vegetable samples. If desired,combinations of fruits and vegetables can be used together such that thecombined ORAC value of the combination is over about 1000 per 100 grams.If desired, the fruits and vegetables, combinations thereof, orindividual fractions can be as an extract and/or powdered form.

The benefits of high antioxidant containing foods are exemplified by theso called Mediterranean Diet, which is rich in plant derived bioactivephytochemicals and has been correlated to lower rates of cardiovasculardisease. For example, lycopene is a natural carotene found in tomato, anessential component of the Mediterranean diet, and functions at least asan antioxidant scavenger.

Aging, metabolic and hormonal changes related to aging, exposure toenvironmental conditions (sun exposure, arid environments), etc., canall contribute to changes in general health and wellbeing, and maycontribute to systemic disorders and diseases health. Environmentalexposure such as ultraviolet (UV) radiation damages skin cells and hair.Over the longer term, UV radiation induces degenerative changes in cellsof the skin, fibrous tissue and blood vessels leading to premature skinaging and wrinkles, lentigo, etc. UV exposure directly affects thebilayer making up a cell membrane because it is made up of significantamount of unsaturated lipids that are more prone to attack by freeradicals. Damage by free radicals is assumed to be one of the causativefactors of aging, inflammation and hyper pigmentation. In fact, thestratum corneum has been found to produce significant concentrations offree radicals under UV exposure, damaging DNA, lipids, proteins andcarbohydrates. The oxidization of low density lipoprotein (“badcholesterol”) is thought to be the primary step leading to itsinteraction with macrophages inside the arterial wall and the formationof atherosclerotic plaque. Therefore higher levels of blood antioxidantsare thought to contribute to mitigating the degree of low densitylipoprotein oxidation and plaque formation. Nitric oxide and reactiveoxygen species (ROS) including superoxide anion and hydrogen peroxideare highly reactive oxidant molecules produced by the human body throughnormal metabolism and diet, and also may play a role in certainconditions including the loss of elasticity in skin, development ofcancers, etc., in addition to cardiovascular disease. Antioxidants areprotective compounds that inactivate ROS and delay or prevent oxidativedamage. Medical investigations suggest that regular consumption ofantioxidant-containing foods can reduce the risk of cardiovasculardiseases and various skin conditions and diseases, providing directevidence for the potential systemic benefits of a diet rich inantioxidants.

While antioxidants are ubiquitous in plants, cocoa (Theobroma cacao) andtea (Camellia sinensis) have been found to be particularly rich in aclass of antioxidants called flavanols. A number of human dietaryintervention trials with flavanol-containing cocoa and tea products havedemonstrated improvements in systemic function as well as, for example,regulation in blood pressure and conditions or disorders related tooxidative damage. Flavanols are also found in fruits and vegetables andare linked to certain health benefits linked to, for example, coronaryheart disease and stroke. As with antioxidants including lycopene andother carotenes, flavanols are thought to take part in mechanisms suchas nitric oxide and antioxidant, anti-inflammatory, and antiplateleteffects to improve endothelial function, lipid levels, blood pressureand insulin resistance, particularly with respect to preventing theoxidization of low density lipoprotein, and can contribute to mitigatingthe effect of free radical damage on the integument, youthful skinappearance, beauty, and maintenance of integument health and well-being.

Various antioxidant containing compounds, supplements, andnutraceuticals can be included in the functional food compositionsdescribed herein in quantities sufficient to correlate with recommendeddaily allowances, for the maintenance of general health, treatment andprevention of systemic disorders, diseases and related conditions, andare beneficial supplementations to normal dietary intake. Otherantioxidant compounds include bioflavonoids such as esveratrol,quercetin, rutin, catechin, epichatechins, proanthocyanidins, andcombinations thereof. These bioflavonoids can be derived from variousplants including, for example, Camellia sinensis, Theobroma cacao (cocoaflavanols) and species, varieties, cultivars, thereof. Bioflavonoids canalso be derived from or found in various plant extracts including, butnot limited to, acai berry extract, raspberry extract, cranberryextract, pomegranate extract, plum extract, cherry extract, rosemaryextract, etc. Isoflavones are used as membrane particles, including, butnot limited to, genistein, daidzein, biochanin A, and formononetin.Carotenes contemplated for use as antioxidant compounds includeα-carotene, β-carotene, γ-carotene, δ-carotene, ε-carotene, lycopene,cryptoxanthin, lutein, zeaxathin, apocarotenal astaxanthin,canthaxanthin, lutein/lutein esters, etc. Lycopene is one of the mostpotent antioxidants, with activity twice as high as that of β-caroteneand tenfold higher than α-tocopherol. Fruits and vegetables that arehigh in lycopene include gac, tomatoes, watermelon, pink grapefruit,pink guava, papaya, seabuckthorn, wolfberry,goji, a berry relative oftomato, and rosehip. The lycopene content of tomatoes depends on speciesand increases as the fruit ripens. Vitamins are contemplated for use inthe functional food described herein and include vitamin C, vitamin Eand vitamin A, all having high antioxidant capacity. All antioxidantcompounds contemplated for use herein include bioavailable forms ofantioxidants and bioactive derivatives thereof, salts thereof, andbioactive metabolic intermediates thereof.

Other compounds can be used exclusively or in combination with theantioxidant containing compounds of the functional food compositionsdescribed herein. If desired, dietary fibers can also be incorporatedwithin the functional food composition as described herein. Dietaryfiber is the edible parts of plants or analogous carbohydrates that areresistant to digestion and absorption in the human small intestine, withcomplete or partial fermentation in the large intestine. Dietary fiberincludes polysaccharides, oligosaccharides, lignin, and associated plantsubstances. Dietary fibers promote beneficial physiologic effectsincluding laxation, and/or constipation relief, and/or blood cholesterolattenuation, and/or blood glucose attenuation. Dietary fibers alsoenhance a satiety effect, wherein food portions can become effectivelysmaller while maintaining a feeling of fullness after a meal.

Nutraceuticals are generally thought of as food or food product thatreportedly provides health and medical benefits, including theprevention and treatment of disease, and can be defined as a productisolated or purified from foods that is generally sold in medicinalforms not usually associated with food. A nutraceutical may have aphysiological benefit or provide protection against chronic disease.Such nutraceutical products may range from isolated nutrients, vitaminsand minerals, other dietary supplements, and herbal products. Withrecent developments in cellular-level nutraceutical agents, researchers,and medical practitioners are developing templates for integrating andassessing information from clinical studies on complementary andalternative therapies into responsible medical practice.

Functional Food Compositions with Antioxidants

In general, vegetables, fruits, spices, berries and legumes, with highantioxidant ORAC values for use as an antioxidant containing compoundcan include, without limitation, broccoli, broccoli sprout extract,tomato, carrots, kale, brussel sprouts, cocoa beans, chokeberry, redbeans, blueberries, kidney beans, pinto beans, cranberry, artichokehearts, blackberry, prune, raspberry, strawberry, red delicious andgranny smith apples, black plum, russet potato, black bean, plum, galaapple, pecans, sweet cherry, pomegranate, blackcurrant, figs, guava,oranges, mango, grapes, clove, cinnamon, oregano, turmeric, cumin,parsley, basil, curry powder, mustard seed, ginger, pepper, chilipowder, paprika, garlic, coriander, cardamom, sage, thyme, marjoram,tarragon, peppermint, oregano, savory, basil, dill weed, pears, peaches,raisins, cabbage, artichokes, broccoli, asparagus, avocado, beetrootspinach, collard greens, etc. If desired, the ORAC value provided theantioxidant containing compound and/or mixtures and combinations ofcompounds is at least about 1000 per 100 grams, at least about 2000 per100 grams, at least about 3000 per 100 grams, at least about 4000 per100 grams, at least about 5000 per 100 grams, at least about 6000 per100 grams, at least about 7000 per 100 grams, at least about 8000 per100 grams, at least about 9000 per 100 grams, at least about 10,000 per100 grams, at least about 15,000 per 100 grams, at least about 20,000per 100 grams, at least about 25,000 per 100 grams, at least about30,000 per 100 grams, at least about 35,000 per 100 grams, at leastabout 40,000 per 100 grams, at least about 45,000 per 100 grams, atleast about 50,000 per 100 grams, at least about 55,000 per 100 grams,at least about 60,000 per 100 grams, at least about 65,000 per 100grams, at least about 70,000 per 100 grams, at least about 75,000 per100 grams, at least about 80,000 per 100 grams.

In general antioxidants contemplated for use for the functional foodcomposition as described herein can include, without limitationcarotenes, bioflavonoids (flavonoids, isoflavones, neoflavonals),tocopherol, tocotrienol, lipoic acid, melatonin, superoxide dismutase,coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, seleniumand ascorbic acid. Carotenes contemplated for use as membrane particlesinclude α-carotene, β-carotene, γ-carotene, δ-carotene, ε-carotene,lycopene, cryptoxanthin, lutein, zeaxathin, apocarotenal astaxanthin,canthaxanthin, lutein/lutein esters, etc. If desired, the amount ofcarotene in the functional food composition serving as described hereincan be up to about 1 milligram (mg), up to about 5 mg, up to about 10mg, up to about 15 mg, up to about 20 mg, up to about 25 mg, up to about30 mg, up to about 35 mg, up to about 35 mg, up to about 40 mg, up toabout 45 mg, up to about 50 mg, up to about 60 mg, up to about 70 mg, upto about 80 mg, up to about 90 mg, up to about 100 mg. Bioflavonoidsused for the functional food composition described herein includeesveratrol, quercetin, rutin, catechin, epichatechins,proanthocyanidins, and combinations thereof. Bioflavonoids can bederived from various plants including, for example, Camellia sinensis,Theobroma cacao (cocoa flavanols) and species, varieties, cultivars,thereof. Bioflavonoids can also be derived from or found in variousplant extracts including, but not limited to, acai berry extract,raspberry extract, cranberry extract, pomegranate extract, plum extract,cherry extract, rosemary extract, etc. Isoflavones are used as membraneparticles, including, but not limited to, genistein, daidzein, biochaninA, and formononetin. If desired, the amount of bioflavonoid in thefunctional food composition serving as described herein can be up toabout up to about 50 mg, up to about 100 mg, up to about 150 mg, up toabout 200 mg, up to about 250 mg, up to about 300 mg, up to about 350mg, up to about 400 mg, up to about 450 mg, up to about 500 mg, up toabout 600 mg, up to about 700 mg, up to about 800 mg, up to about 900mg, up to about 1000 mg.

Total ORAC provided by the antioxidant containing compound per servingof the functional food described herein can be at least about 2000, atleast about 3000, at least about 4000, at least about 5000, at leastabout 6000, at least about 7000, at least about 8000, at least about9000, at least about 10,000, at least about 15,000, at least about20,000, and higher.

Dietary fibers for the functional food composition as described hereincan include, both soluble and insoluble dietary fibers, including, butnot limited to, galacto-oligosaccharides, inulin and oligofructose(fructo-oligosaccharide), isomalto-oligosaccharides, lactulose,lactosucrose, transgalacto-oligosaccharides, soybean oligosaccharides,tagatose, xylo-oligosaccharides, and combinations thereof. The dietaryfiber can be an oligosaccharide fructan including, but not limited to,fructo-oligosaccharide and derivatives thereof of inulin(poly-D-fructose, itself derived from various plant products includingbananas, onions, chicory root, garlic, asparagus, barley, wheat, jicama,leeks, etc.) or from transfructosylation action of a β-fructosidase asused, for example, by Aspergillus sp. metabolically active on sucrose.Dietary fibers can be derived from plants and plant products including,but not limited to, artichoke, dandelion greens, bran, flour, legumes,oats, citrus fruits, apples, and root vegetables, cane sugar, etc. Ifdesired, the amount of total dietary fiber per function food serving canbe less than about 1 gram, less than about 2.5 grams, less than about 5grams, less than about 7.5 grams, less than about 10 grams, less thanabout 12.5 grams, less than about 15 grams, less than about 17.5 grams,less than about 20 grams.

Uses of Antioxidant Functional Food Compositions

Functional food compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases and/or maintenance of a healthy state, as well asprovide a source of antioxidant for the promotion and maintenance ofgeneral health, and mitigation of disease and disorder treatment. Thesebenefits can be provided to a consumer when new ingredients or more ofan existing ingredient are added to a food so that an added healthbenefit from the food product is gained.

Supplementing a diet with antioxidant containing compounds deliverablein the functional foods as described herein is useful for prevention andtreatment of a variety of conditions and disorders, particularly thoserelated to free-radical damage, as well as for general health andwellness maintenance.

The functional food compositions as described herein increase theeffective delivered concentration of such useful antioxidants, and canbe formulated for daily dietary supplements, preventative treatment andmitigation of other disorders related to environmental damage and aging.

XI. Overview of the β-Glucan/Probiotic Functional Food Composition

The disclosure relates to functional food compositions that contain aβ-glucan and a probiotic when, upon ingestion, promote immune responsesand immunity related health and well-being. The functional foodcomposition contains an edible or potable substance that is encapsulatedin an edible membrane, and further contains a probiotic and a β-glucan.The functional food compositions described herein provides a convenientand improved way for individuals to consume probiotics and β-glucan inquantities needed to promote immunological health and well-being.

Generally, functional food compositions are intended to provide ahealthy benefit to a consumer. The benefit can be qualitative,quantitative or subjective and include, for example, health promotion,disease prevention, etc. Some benefits include providing an importantnutritive food source, vitamins and supplements, β-glucan or probiotics,which contribute to the prevention, management and treatment of chronicdiseases or disorders. This health improvement benefit can also beprovided to a consumer when additional ingredients or more of anexisting ingredient are added to a food so that the benefit from thefood product is gained. However, delivery systems for some beneficialhealth compounds including β-glucan and probiotics often have reducedbioavavailability, resulting in suboptimal quantities of these compoundsbeing made available to the consumer.

The functional food compositions described herein provide for asignificant improvement in the delivery, viability and concentration ofβ-glucan and probiotic compounds useful to a consumer. Within thesecompositions, the β-glucan and probiotic compounds can becompartmentalized within the edible or potable substance, theencapsulating membrane, or both. Upon mastication and ingestion, theβ-glucan and probiotic are released from the functional food compositionto provide an immediately available nutrition and edible source. Thefunctional food compositions can thus be designed to have one or moreβ-glucan and probiotic compounds in an effective combination andconcentration desirable for the specific needs of the consumer orpatient, for example, the elderly, adult and children consumers, andmedical patients.

The functional food compositions described herein are designed toprovide β-glucan and probiotic compounds in biologically effectivequantities superior to commonly used products. The compositions areparticularly well-suited for providing a larger active ingredient loadas well as being amenable for controlling the actual portion size for anintended health benefit. Functional food compositions as describedherein can provide up to and above several times the suggested minimumdosages in a sample serving, or provide combinations of β-glucan andprobiotic compounds, nutraceuticals and supplements up to and aboveseveral times the suggested minimum dosages in a single serving that isboth convenient and appetizing. For example, an eight ounce serving ofcommercial yogurt in plastic containers commonly provides a microbialload of less than 1 billion colony forming units (BCFU), far below abacterial load level sufficient to provide health benefits. Thecompositions described herein can be designed to provide up to 100BCFU's. A functional food delivering a combination of β-glucan andprobiotics in a single serving composition can contribute to theprevention, cessation or mitigation of a multitude of health relatedconditions and diseases. In addition, a general state of health andwellness can result from a healthy diet supplemented with β-glucan andlive and/or heat killed probiotic compounds.

These functional food compositions also enhance the stability, gustatoryexperience, and delivery of functional biologically active compounds.Functional food compositions contain and protect ingestible/ediblesubstances, such as ice cream, yogurts, etc., and probiotics or β-glucanby encapsulating the substance within edible or biodegradable membranes.The edible membranes of these compositions can be formed from variousnatural polymeric substances allowing different compositions to beeasily transported and consumed.

Considerations for the choice of probiotic or probiotic combinations foruse in the function food compositions are that, if desired, theprobiotic remain viable until ingestion in a biologically effectiveconcentration, and the probiotic be able to confer a health benefit toand/or use for treatment of a gastro-intestinal, immune or othersystemic disorder in the host organism.

In some instances, heat-treated probiotics or probiotics that areotherwise rendered non-viable, and/or immune enhancing constituentsderived from heat killed or non-viable probiotics, are preferred and areused in the compositions described herein. For example, heat killedLactobacillis species have been shown to augment innate and acquiredimmunity in mammals.

In all instances, it is desirable that these food compositions (product)include effectual probiotics to enhance the immune response otherwiseconfer a health benefit to a host organism ingesting the probiotic.

β-glucans are major biological structural components of yeasts, fungiand certain bacteria. β-glucans are polysaccharides that can be obtainedfrom natural sources, and consist of a backbone of (1,3)-β-glycosidiclinked D-glucose subunits, and having regularly or irregularly placedβ-(1,6)-linked (1,3)-β glycosidic linked D-glucose side chains ofvarious lengths. The various side chain combinations can affectimmunological effects due to resulting changes in the β-glucansolubility, mass, tertiary structure, branching patterns andelectrostatic charge. Innate immune responses to invading pathogensdepend primarily on the recognition of pathogen-associated molecularpatterns (PAMPs) by pattern recognition receptors (PRR). β-glucans areknown as a major PAMP for the PPR-mediated sensing of fungal infection.β-glucans polymers are able to bind to the dectin receptor (an importantPRR for beta-glucans), to activate the dectin-1 signaling to enhancephagocytosis, presentation of macrophages and dendritic cells, andinduces the adaptive immune response.

Generally, the probiotics and β-glucans as used herein are taken 1) toenhance the physical well-being or state of health of the end user, 2)as a health related supplement, 3) as supplements for enhancing immuneresponse or mitigation of autoimmune responses, and/or 4) as supplementsto maintain a healthy immune system. Diets supplemented with probioticsand β-glucans can also add to a higher quality or perceived quality ofthe health state of the end user.

Health benefit aspects contemplated for use of the β-glucans andprobiotic functional food compositions described herein include relieffrom intestinal inflammation, beneficial pathogen and antigen response,decreased time of infection, decreased severity of infection, preventionof infection, etc. Health and wellness preventative treatment withprobiotics includes decreased immunological response time, enhancedhumoral immune response, stimulation of non-specific host resistance tomicrobial pathogens, and modulation of the host's immune responses topotentially harmful antigens, and regulation of hypersensitivityreactions, including statistically significant decreases in the onset ofupper respiratory tract infections, demonstrated augmentation ofacquired immunity, reduction in the severity of cold and flu symptoms,and reduction in nasal and ocular symptoms due to ragwood allergy.Additionally, β-glucans and probiotics may beneficially affect the hostby augmenting the host intestinal microbial population beyond the amountalready existing, thus possibly inhibiting unhealthy or harmfulpathogens.

As described in more detail herein, the common probiotics include lacticacid bacteria, bifidobacteria, yeasts and bacilli. Often theseprobiotics are consumed as part of a fermented food source, (e.g.,yogurt, soy yogurt, etc.) with added live microbiological cultures.

Measurable outcomes for general health maintenance can be determinedquantitatively and/or qualitatively by monitoring, for example, apatient's or consumer's change in composition of intestinal microflora,decreased incidence of pathological infection, decreased intensity ofpathological infection, decreased recovery time from pathologicalinfection, and increased possibly feelings of well-being. Forpretreatment/prevention of diseases, conditions and/or syndromes, theconsumer or patient may show milder symptoms or no symptoms. In acuteconditions for which the consumer or patient is using the functionalfood composition, for example diarrheal conditions (i.e. traveler's,antibiotic or viral) or infection from viruses related to the commoncold, the outcome would be faster resolution and reduction in severityfor treatment. In general, a reduction in discomfort related toinfection or an immune response, and improvement in quality of life andability to perform activities of daily living are all indicators of thehealth benefits when consuming the functional food compositionsdescribed herein.

β-Glucan and Probiotic Compositions

Common probiotics include lactic acid bacteria, bifidobacteria, yeastsand bacilli, and are often consumed as part of a fermented food source,(e.g., yogurt, soy yogurt, etc.) with added live microbiologicalcultures. Probiotics in concentration and/or type contained within thefunctional food compositions included herein may be used in addition tonatural levels of probiotics in the food source. Alternatively,probiotics as described herein may be used in food sources with no knownnatural probiotic levels. Inactivated probiotics, for example heat orchemically inactivated probiotics, having an antigenic effect may beused in the compositions described herein.

Probiotics for use in the foods described herein include, but are notlimited to, Aspergillus niger, Aspergillus oryzae, Bacillus coagulans,Bacillus lentus, Bacillus licheniformis, Bacillus pumilus, Bacillussubtilis, Bacteroides amylophilus, Bacteroides capillosus, Bacteroidesruminocola, Bacteroides suis, Bifidobacterium animalis, Bifidobacteriumbifidum, Bifidobacterium breve, Bifidobacterium infantis,Bifidobacterium licheniformis, Bifidobacterium longum, Bifidobacteriumpseudo longum, Bifidobacterium subtilus, Bifidobacterium thermophilum,Enterococcus cremoris, Enterococcus diacetylactis, Enterococcus faecium,Enterococcus thermophilus, Lactobacillus acidophilus, Lactobacillusamylovorus, Lactobacillus ansporogenes, Lactobacillus brevis,Lactobacillus buchneri, Lactobacillus bulgaris, Lactobacillus casei,Lactobacillus caucasicus, Lactobacillus cellobiosus, Lactobacilluscrispatus, Lactobacillus curvatus, Lactobacillus delbrueckii,Lactobacillus farciminis, Lactobacillus fermentum, Lactobacillusgallinarum, Lactobacillus gasseri, Lactobacillus GG, Lactobacillushelveticus, Lactobacillus johnsonii, Lactobacillus kefir, Lactobacilluslactis, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillusrhamnosus (casei), Lactobacillus salivarius, Lactococcus lactis,Leuconostoc mesenteroides, Pediococcus acidilactici, Pediococcusacidilacticii, Pediococcus cerevisiae, Pediococcus pentosaceus,Propionbacterium freudenreichii, Propionibacterium shermanii,Saccharomyces boulardii, Saccharomyces cerevisiae, Shewanellacolwelliana, Shewanella olleyana, Shewanella putrefaciens, Streptococcuscremoris, Streptococcus faecium, Streptococcus infantis, Streptococcusthermophilus, Vagococcus fluvialis, Bacillus coagulans GBI-30, 6086,Bifidobacterium animalis DN 173 010, Bifidobacterium animalis subsp.lactis BB-12, Bifidobacterium breve Yakult, Bifidobacterium infantis35624, Bifidobacterium lactis HN019 (DR10), Bifidobacterium longumBB536, Bifidobacterium longum subsp. infantis 35624, Enterococcus LAB SF68, Escerichia coli Nissle 1917, Lactobacillus acidophilus NCFM,Lactobacillus acidophilus LA-5, Lactobacillus acidophilus NCFM,Lactobacillus casei subspecies casei, Lactobacillus casei DN-114 001,Lactobacillus casei CRL431, Lactobacillus casei F19, Lactobacillus caseiShirota, Lactobacillus delbrueckii subspecies bulgaricus, Lactobacillusdelbrueckii subspecies lactis, Lactobacillus paracasei St11 (orNCC2461), Lactobacillus johnsonii La1 (Lj1), Lactobacillus johnsoniiNCC533, Lactobacillus plantarum 299v, Lactobacillus rhamnosus ATCC 53013(LG), Lactobacillus rhamnosus LB21, Lactobacillus reuteri ATCC 55730,Lactobacillus salivarius (UCC118), Lactobacillus reuteri SD2112,Lactococcus lactis L1A, Lactococcus lactis subspecies lactis,Lactococcus lactis subspecies lactis biovariant diacetylactis,Lactococcus lactis subspecies cremoris, Leuconostoc mesenteroidessubspecies cremoris, Leuconostoc mesenteroides subspecies dextranicum,Lactobacillus reuteri Protectis (DSM 17938, daughter strain of ATCC55730), Saccharomyces cerevisiae boulardii, Saccharomyces cerevisiaeboulardii (lyo), Lactobacillus bulgaricus, Streptococcus thermophiles,Bifidobacterium spp, and any other strains, derivatives, andcombinations thereof, including, but not limited to, Lactobacillusrhamnosus GR-1 & Lactobacillus reuteri RC-14, Lactobacillus acidophilusCL 1285 & Lactobacillus casei Lbc80r, Lactobacillus rhamnosus (ATTSD5675) & Lactobacillus acidophilus (STCC SD5221), VSL #3 (a combinationof 1 strain of Streptococcus thermophiles, four strains of Lactobacillusspecies, & three Bifidobacterium species strains from Sigma-TauPharmaceuticals), Lactobacillus acidophilus NCFM & Bifidobacteriumbifidum BB-12, Lactobacillus acidophilus CUL60 & Bifidobacterium bifidumCUL20, Lactobacillus acidophilus CL1285 & Lactobacillus casei LBC80R,Lactobacillus helveticus R0052 & Lactobacillus rhamnosus R0011, Bacillusclausii (strains O/C, NR, SIN and T), Lactobacillus plantarum HEAL 9 &Lactobacillus paracasei 8700:2, other genetic variants thereof, andcombinations and other combinations thereof. In certain instances theprobiotic may be heat killed or otherwise rendered non-viable andincluded in the functional food product described herein. In still otherinstances, constituents of the heat killed or otherwise renderednon-viable probiotic may be used in the functional foods describedherein.

When the dosage or intake of the effective dose of the activeingredients of the functional food composition are indicated by thenumber (concentration) of the probiotic, it is preferable that theintake is about 0.5-1.0 (BCFU) or more per day, more preferably about 10BCFU's or more per day, more preferably about 50 BCFU's or more per day,more preferably about 100 BCFU's or more per day. The concentration ofprobiotic to be contained in an individual product serving is determinedaccording to the amount of servings ingested per day. The concentrationof probiotic present in the functional food composition can be less thanabout 1 BCFU's, about 1 to about 2 BCFU's, about 3 to about 5 BCFU's,about 5 to about 10 BCFU's, about 10 to about 20 BCFU's, about 20 toabout 30 BCFU's, about 30 to about 40 BCFU's, about 40 to about 50BCFU's, about 50 to about 60 BCFU's, about 60 to about 70 BCFU's, about70 to about 80 BCFU's, about 80 to about 90 BCFU's, about 90 to about100 or more BCFU's.

When the dosage or intake of the effective dose of the activeingredients of the functional food composition are indicated by the massof the probiotic, it is preferable that the intake is about 1 mg toabout 10 mg, about 10 mg to about 20 mg, about 20 mg to about 30 mg,about 30 mg to about 40 mg, about 40 mg to about 50 mg, about 50 mg toabout 75 mg, about 75 mg to about 100 mg, about 100 mg to about 150 mg,about 150 mg to about 200 mg, about 200 mg to about 250 mg, about 250 mgto about 300 mg, about 300 mg to about 350 mg, about 350 mg to about 400mg, about 400 mg to about 450 mg, about 450 mg to about 500 mg, about500 mg to about 600 mg, about 600 mg to about 700 mg, about 700 mg toabout 800 mg, about 800 mg to about 900 mg, about 900 mg to about 1000mg, or more.

In the functional food compositions described herein, β-glucans to beused in the compositions can be derived or obtained from yeasts, fungi,certain bacterial species, plants such as seaweed, or combinationsthereof. For example, yeasts such as baker's yeast (Saccharomycescerevisiae), cereal grains including barley, rye, wheat, oats, andmushrooms (for example shiitake, maitake, reishi, shimeji and oystervarieties) are all common sources of β-glucan. Specifically,(1,3)-(1,6)-β-glucan has been shown to have clinical effect in boostingimmune responses; however compositions with (1,3) β-glucan have alsobeen shown to enhance immune responses. In certain embodiments, purifiedforms of (1,3)-(1,6)-β-glucan, for example from Saccharomycescerevisiae, are used in the functional food composition.

Concentrations of the β-glucan used for an effective dose depend on thepurity of the β-glucan, but can be daily doses of up to about 1milligram (mg), 2 mgs, 5 mgs, 10 mgs, 20 mgs, 30 mgs, 40 mgs, 50 mgs, 75mgs, 100 mgs, 200 mgs, 300 mgs, 400 mgs, 500 mgs, 600 mgs, 700 mgs, 800mgs, 900 mgs, 1000 mgs, 1500 mgs, 2000 mgs, 2500 mgs, 3000 mgs, 3500mgs, 4000 mgs, 4500 mgs, 5000 mgs. In certain embodiments,concentrations are desired to be about 200 mg to about 300 mg.

If desired, additional compounds are included in the functional foodcomposition to improve or maintain healthy conditions in the digestivetract and/or enhance or modify the microflora and ecologicalbiochemistry to optimize the effects of the probiotic and β-glucancomposition. Additional compounds can be insoluble fibers and/or solublefibers generally not specifically utilized by the probiotic; probioticextracts (e.g., probiotic exudates and/or non-viable micro-organisms);digestive enzymes including, but not limited to, pancreatin,pancrelipase, papain, pepsin, diatase, ox bile, lactase, protease,amylase, lipase, bromelain, cellulose, malt diastase, glucoamylase,hemicellulose, beta-gluconase, phytase, trypsin, aminopeptidase,chymotrypsin, carboxypeptidase, elastase, maltase, sucrose, etc.;supplements including, but not limited to, glutamine, peppermint,artichoke, ginger, fennel, licorice root, anise seed; and compoundsuseful for immune health including, but not limited to, vitamins (A, E,C, D); minerals (zinc, selenium); plant derived materials such asEchinacea, ashwaganda, elderberry, etc.; and yeast extracts.

Uses of β-Glucan/Probiotic Functional Foods

Edible transport compositions described herein are contemplated toprovide a functional benefit to a consumer (“functional food”).Functional foods are formulated to provide an important nutritive foodsource that contributes to the prevention, management and/or treatmentof chronic diseases, pathogenic infections and infectious conditions,and autoimmune regulation. This benefit can be provided to a consumerwhen new ingredients or more of an existing ingredient are added to afood so that an added health benefit from the food product is gained.Probiotics and β-glucans are useful for a variety of health relatedconditions as well as general health maintenance. Immune systemeffectiveness is enhanced with the combination of probiotic/β-glucanintake. The edible transport compositions as described herein increasethe effective delivered concentration of such usefulprobiotics/β-glucan, and can be formulated for daily dietarysupplements, preventative treatment of pathogenic conditions, treatmentof nosocomial infections, for clinical applications treating systemicdisease states, etc.

Probiotics and β-glucans are have been used as separate indications byphysicians and nutritionists to treat, for example, candidiasis,infections by opportunistic bacteria and viruses establishing aftertrauma, stress, as an antioxidant, or the establishment of normal floraafter treatment with antibiotics. In the functional foods describedherein, it is preferred that combinations of live and/or non-viableprobiotic are used in combination with a β-glucan in the finalnutritional functional food product.

In some embodiments, the functional food compositions are used to assistin preventing or mitigating radiation burns. Often the probiotics arerecommended by physicians and nutritionists to treat, for example,candidiasis, infections by opportunistic bacteria establishing aftertrauma, or the establishment of normal flora after treatment withantibiotics. In certain embodiments the functional food described hereincan be used to support a cancer treatment regimen (being effective inpromoting macrophage generation targeting cancer cells) or for thepromotion of the generation of immunocytes in bone marrow.

Probiotics and β-glucans may also play a role in benefitting the immunesystem by, for example, competing against pathogens though competitiveinhibition (e.g. opportunistic bacteria such as C. difficile) viaenhancing natural flora, enhancing phagocytosis by white blood cells,and enhancing or increasing the production of certain antibodies and/orT-lymphocytes. Modulation of the immune system by regulatinginflammatory and hypersensitivity responses related to cytokineregulation and function is also found to be correlated to intake ofprobiotics and β-glucans, as is the management of diarrhea andinflammatory bowel disease.

The functional food described herein may play a role in the treatmentfor systemic disorders such as high cholesterol and high blood pressure.Ingestion of sufficient levels of probiotics is correlated with loweringcholesterol through a mechanism thought to be involved with thebreakdown of bile in the intestinal tract to a metabolite that is unableto be reabsorbed. Additionally, reduction in blood pressure has beencorrelated with intake of fermented dairy products. Thus, it is believedthat angiotelisin-converting-enzyme inhibitors or inhibitor likepeptides are produced by the probiotic. Maintenance treatment in anormal daily diet (1-10 BCFU's) can be useful for management of systemicdisorders such as high cholesterol and/or high blood pressure.

Membranes Encapsulating Compositions

Embodiments of transport system described herein can have, e.g., varyingshell or membrane thickness, one or more of a variety of chemicalconstituents, varying numbers of membranes, various consumable payloads,various shapes, and are constructed from various shell/membraneproperties to provide a variety of flavors and textures and membranecharacteristics. See, for example, PCT International Publication No. WO2011/103594 and PCT International Application No. PCT/US2013/023500,which are incorporated herein by reference in their entirety.

Membranes and shells of the functional food compositions may be made byusing any one of many edible and/or biodegradable polymers. FIG. 1illustrates alginate (alginic acid) as an example of a polymer that canbe used in forming a membrane of transport systems. Alginate is ananionic, polymeric polysaccharide, widely present in the cell walls ofbrown algae. It is a copolymer -(M)_(n)-(G)_(n)- segments composed ofmannuronate M (mannuronic acid) and guluronate G (guluronic acid)monomeric subunits. The values of m and n, the ratio m/n, and the spacedistribution between M and G (i.e. presence of consecutive G-subunitsand M-subunits, or randomly organized subunits) all play key roles inthe chemical and physical properties of the final membrane. To inducerapid gelation by electrostatic cross-linking, the naturally present Na⁺ions are removed and replaced by divalent cations (e.g., Ca²⁺ or anothermulti-valent cation such as Mg²⁺; FIG. 2).

Generally, membrane encapsulated compositions are constructed that usevarious particles, particulates and polymers, in combination orseparately, to create desired properties of strength, stability,permeability, edibility and biodegradability for the transport systemsto be easily moved and consumed.

For example, functional food compositions can be encased in apolysaccharide membrane, for example, an alginate membrane. Ingestibleparticles can be embedded in the membrane to improve the physical,chemical and/or physico-chemical performance characteristics suitablefor particular payloads (i.e. edible or potable substances), including,but not limited to, diffusion characteristics, pore size of themembrane, elasticity, etc. When particles are charged and possess thesame charge state as other membrane polymers or particulates, membranecomponent concentrations can vary (for example, decreasing the membranepolymer concentration and increasing the membrane particulateconcentration) while maintaining or optimizing membrane performance.When particles carry the opposite charge state as alginate polymers orparticulates, the need for a calcium solution or another multivalent ioncan be minimized or eliminated by using particles to bind with alginatesor another charged polymer. For non-alginate based systems, combinationsof homogenous particles can be used to encapsulate the edible material,or can be used in combination with polymers at lower weight %-by-massthan the particles (for example, less than 80%, less than 70%, less than60%, less than 50%, less than 40%, less than 30%, less than 20%, lessthan 10% polymer). In some applications, a thinner membrane is desirableto encapsulate a larger quantity of ingestible material, which may havefurther advantages of taste and texture. Particles contemplated hereininclude large food particles, for example greater than 1 millimeter(linseeds, sesame seeds, poppy seeds, chia seeds, chopped or pulverizedfoods including fruits, fruit skins, vegetables, etc.), small grains,and pulverized seeds, nuts, etc. In some applications, compositions useparticulates less than about 1 millimeter.

Generally, polysaccharide polymers are used as the membrane polymer.Polysaccharide polymer based membranes are porous, with porositydetermined by the chemical content and 2- and 3-dimensional geometry ofthe polymeric structure of the membrane, for example the structure ofthe polysaccharide chain. As described herein, various physical andchemical characteristics of the particulates are matched to the membranestructure and chemistry to achieve a desired effect, such as increasedimpermeability, elasticity, membrane strength-to-weight ratio, color,syneresis, etc. The membrane can have a strength sufficient to support avolume of water, for example 1 cubic centimeter (cc), 5 cc, 10 cc, 20cc, 30 cc, 40 cc, 50 cc, 100 cc, 200 cc, 300 cc, 400 cc, 500 cc, 600 cc,700 cc, 800 cc, 900 cc, 1000 cc, 1200 cc, 1400 cc, 1600 cc, 1800 cc,2000 cc, 3000 cc, 4000 cc, 5000 cc, 6000 cc, 7000 cc, 8000 cc, 9000 cc,10000 cc, or more, without rupturing, and when handled or transported.The membrane is preferably a continuous membrane, fully encapsulating anedible or potable substance such that the edible or potable substance isfully contained and does not leak out from within encapsulation due tomechanical stress, rupture, shearing, etc. The cross-linked matrix canhave a thickness from about 10 microns to about 200 millimeters. Theedible or potable substance can be coated and/or embedded in a pluralityof membranes.

The particulates used for the membrane can be about 0.01 microns, atabout 0.1 microns, at about 0.1 to 1.0 microns, at about 0.1 to 10microns, at about 0.1 to 100 microns, at about 0.01 to about 1millimeter or to about 3 millimeters, or at about 0.1 to about 1millimeter or to about 3 millimeters. The size of the particulates maybe important for embedment characteristics into the porous structure ofthe membrane.

In some applications, it may be desirable that some of the particulatesare incorporated into the membrane and a layer of particulates remainunincorporated, forming a layer next to a membrane or between two ormore membrane layers. The additional particulate layer can be engineeredto alter, for example, permeability, elasticity, strength, durability,syneresis, hygroscopy, hydrophobicity, etc., changes across and withinmembrane layers. Thus, the chemical nature of the particulates, forexample if a hydrophobic particulate is used, can enhance the impedanceof liquid diffusion across an inner layer to an outer layer surfaceboundary. In other aspects, particulates can be layered so that theparticulate layer has multiple effects, for example an innerimpermeability layer, a middle flavor/texture/payload (e.g. apharmaceutical or supplement) layer, and an outer strength improvinglayer.

Particles as described herein can be both in the edible or potablesubstance and in the membrane. The particles in the membrane and in theedible or potable substance can be the same particles or differentparticles, can be uniform size or exhibit a range of sizes, and/orexhibit similar or different physical-chemical characteristics.

Various membrane polymers are contemplated for use in the membraneforming layers. Polysaccharide polymers contemplated herein include, butare not limited to, shellac, various fibers and hydrocolloids such asalginate, an agar, a starch, a gelatin, carrageenan, xanthan gum, gellangum, galactomannan, gum arabic, a pectin, a milk protein, a cellulosic,gum tragacanth and karaya, xyloglucan, curdlan, a cereal β-glucan,soluble soybean polysaccharide, a bacterial cellulose, amicrocrystalline cellulose, chitosan, inulin, an emulsifying polymer,konjac mannan/konjac glucomannan, a seed gum, and pullulan. Combinationsof these polysaccharides are also contemplated herein.

Other membrane compounds considered for use as structure formingcompounds to modify or be used in combination with a polymer-basedmembrane (for example, a membrane consisting of a polysaccharide)include bagasse, tapioca, chitosan, polylactic acid, processed seaweed,chocolate, starch, gum arabic, cellulose based fibers, natural andsynthetic amino acids and polymers thereof, proteins and sugars/sugarderivatives, etc. Combinations of these compounds and compositions arealso contemplated herein.

One or more of a variety of ions can be used to polymerize the membraneand for related chemical processes. In, for example, the alginatepolysaccharide membrane, ions are used to form cross-linkages betweenand among individual polymer strands. Various ion/counter ion saltcomplexes are contemplated for use herein, including, but not limitedto, divalent cations such as calcium, potassium, magnesium, manganese,iron, zinc; trivalent cations including, but not limited to, manganeseand iron; and salts thereof including, but not limited to, calciumlactate and calcium chloride.

In certain applications micelles can be formed within membranes andbetween membrane layers and/or between the inner membrane and the edibleor potable substance. Micelles can alter the taste experience or mouthfeel for the final encased product. Additionally, micelles engineeredinto the final membrane coated product may contain other ingestiblesincluding sweeteners, flavors (fruits, herbs and spices, etc.), herbalextracts, energy supplements, dietary supplements, pharmaceuticals, overthe counter drugs, sleep aids, appetite suppressants, weight gainagents, antioxidants, nutraceuticals, confections, etc., andcombinations thereof.

Useful characteristics of membranes described herein can providesufficient barriers to environments and environmental changes, therebyprotecting food compositions, probiotics and prebiotics, by, forexample, prevention or attenuation of dehydration, providing oxygenbarriers, thermal insulation, etc., that increase the length of time theprobiotic and functional food as a whole remains viable.

Encapsulated Compositions

Functional foods are desired to provide health and medical benefits,including the prevention and treatment of disease. Other factors alsoare considered to create a product that is commercially available (e.g.longer shelf life, product stability, etc.) and elicits a pleasurableexperience for the consumer (e.g., flavor, ease of consumption,mouthfeel, etc.). Therefore, some considerations for the choice of foodcomposition used as a carrier for the bioavailable compound includeconsumer taste preference, sufficiency to support desired concentrationsof bioavailable compounds, compatibility of chemical environment betweencomposition and bioavailable compound, compatibility of flavors ofbioavailable compound and composition, and health and/or nutritionalcontent of the composition.

Viability considerations for the choice of probiotic microorganism areinfluenced by the environment provided by the food composition in whichthe probiotic is delivered and ingested. Such considerations include,for example, a physiologically active state within the edible product,environmental temperature, pH, water activity, oxygen level, toxicity ofthe ingredients of the food product, potential for shear forcesencountered during standard food production, and deleterious effectsfrom freeze/thaws during storage and transport. Choice of probiotic cantherefore influence choice of food composition, and vice versa, for thecomposition used as a delivery vehicle.

Taste to the consumer is important and can provide an enjoyablegustatory experience. Enjoyable food compositions and flavors canincrease compliance of usage by consumers (e.g. children and elderly)and patients under clinical administration of the functional food. Forexample, typical flavorings for use in the compositions described hereininclude chocolate, vanilla, mints, natural fruit flavors, etc.

Edible and potable substances contemplated for the functional foodinclude, but are not limited to, frozen dairy products such as frozenyogurts, ice creams, sorbets, gelatos, etc., other dairy products suchas yogurt, fruits, vegetables, meat, a carbohydrate food product,botanicals, confections, and combinations thereof. The substances can bein natural form, puree form, frozen, soft, etc.

Other edible and potable substances that can be used as carriers of thebioavailable compounds include liquids such as water, alcoholicbeverages and mixed drinks, juices, coffee and tea products, softdrinks, liquid confectionary beverages, and combinations thereof.

Additionally, various vitamins, minerals, supplements and nutraceuticalscan fortify the composition, in addition to the bioavailable compoundsused to make the functional food. In general, nutraceuticals provide aphysiological benefit or provide protection against chronic disease.Such products may range from isolated nutrients, dietary supplements andspecific diets to genetically engineered foods, herbal products, andprocessed foods such as cereals, soups, and beverages.

Preparation of an Edible, Membrane Encased Composition

A membrane can be engineered for various functional food applications bybeing, for example, stronger, thinner/thicker, or taste a particularway, with methods in addition to adjusting the properties of an alginatesolution. Adding suspended particles of food, nutraceuticals, compoundsbeneficial to gastrointestinal health, or other particles at leastpartially insoluble in water can achieve desirable properties importantto the consumer and patient.

Often the added particles will be charged (i.e., most particle surfaceshave some charge or zeta potential). This charge can be modified by theway each particle is created, its size, and the nature of the particlesurface. Surfactants can be added to enhance the charged nature and theionic atmosphere of the water can also be modified beneficially. When insolution (e.g., alginate or an aqueous medium), these particles canundergo strong or weak associations with alginate. When in contact withcalcium, for example, particles will form with alginate a gelledmembrane through interaction of the calcium and food particles trappedwithin the membrane, possibly strengthening it, improving flavor, etc.FIG. 3 schematically illustrates the interaction between positivelycharged particles (e.g., Ca²⁺ or Mg²⁺) with negatively charged alginateor food particles.

FIG. 4 illustrates various food compositions having membrane layerscontaining different particles (e.g., edible particles). By way ofexample, membrane layers can include differently sized particles,different types of particles, or different orientations orconfigurations of particles. The functional food compositions can besized to various diameters, from greater than 1.5 centimeters to 2centimeters, 3 centimeters, 4 centimeters, 5 centimeters, 7.5centimeters, 10 centimeters, 15 centimeters, or 20 centimeters, orgreater. Additionally, the functional food compositions can be enclosedin various shells for packaging, transportation, or storage.

Referring to FIGS. 5, 6 and 7 a membrane layer around an ingestiblesubstance can include larger and/or smaller particles suspended in thealginate polymer matrix, providing structural stability to the membraneand helping reduce deformation of the membrane. Such a membrane can havean unusual (e.g., non-spherical) shape. Additionally, particles canreduce evaporation of the aqueous portion of the membrane and/or thefluid inside the membrane, and provide a more rigid and/or less stickysurface for holding the composition.

The membrane layer having both large and small particles has been shownto produce better particle packing and arrangement within the membranelayer, possibly better structural integrity, reduced water evaporationfrom the membrane or the fluid contained therein, and forming moreuseful textures than membrane layers having only large or smallparticles.

Functional food compositions can be formed as non-spherical, non-uniformshapes. Referring to FIG. 8, a membrane can include ridges or featuresfor aesthetic and/or structural purposes. The functional foodcomposition can be made to resemble naturally occurring objects (e.g.,fruits and vegetables) to enhance the appearance of the product as anatural alternative to various pills shaped supplements and the like

Referring to FIG. 9a -c, some functional food compositions can be madewith multiple layers of membranes with particles embedded therein, andfurther have particulate layers between the membrane matrix layers,encasing an edible or potable substance. For example, a probiotic can beembedded in one membrane, and the prebiotic can be embedded in anothermembrane. In other alternatives, more than one probiotic or prebioticcan be used and isolated or embedded in separate membranes of themulti-membrane product.

EXAMPLE 1 Gastrointestinal Health Functional Food Composition

Membrane layer and inner compositions to be used in the functionalnutrition transport systems can include various ingredients to achievedifferent products (e.g., different flavors, textures and ingredientsaddressing specific health purposes) based on the requirements or needsof the intended end user as well as recommended daily values or valuessufficient to achieve a health benefit. Three activities prebiotic andprobiotics are thought to participate in are changing the microbiota,fermentation producing organic acids, producing a health benefit to thehost. Various health benefits include improved digestion, reducedintestinal gas, increased stool transit time, reduced diarrhea, improvedimmune function, increased probiotic CFU counts in stool, etc. Anexample of membrane layer composition and inner composition to beenclosed by the membrane are provided below in Tables 1a/b for aprebiotic/probiotic nutritional product for use in enhancing digestivehealth and/or immunity.

TABLE 1a Inner Frozen Yogurt Amount per individual edible Ingredienttransport vessel Frozen yogurt (e.g. vanilla) 5-15 g Howaru Dophilus(Danisco) 100 BCFU Howaru Bifidus (Danisco) 100 BCFU BC30 (B. coagulans,Ganaden 15 BCFU Biotech)

TABLE 1b Membrane Amount per individual edible Ingredient transportvessel Sodium Alginate 0.01-0.4 g Fructo-Oligosaccharide, 3 g (up toabout 30 grams, Galacto-oligosaccharide, Inulin, optionally) chicoryroot, etc. (eg. VitaFiber) Water 1.0-4.0 Calcium lactate <0.5 gFruit/Flavoring 1.0-15 g Sweetener 0.25-1.0 g Sodium Citrate (optional)0.025-0.1 g Stabilizer 0.025-0.1 g

EXAMPLE 2 Integument Health Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 2a/b for a bioflavonoid,carotene and elastic tissue component product, to deliver dailyrecommended or desired concentrations bioavailable compounds for beautyand health and wellness. Concentrations can be varied to provide thesame concentrations in more than one serving.

TABLE 2a Inner Ice Cream Ingredient Amount per serving Non- or low-fatice cream 5-20 g (vanilla, chocolate) Calcium lactate pentahydrate 155mgs Magnesium amino acid chelate 155 mgs Zinc gluconate dihydrate 7 mgs

TABLE 2b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 g Calcium lactate <0.5 g Chocolate (cacao paste,1.0-4.0 g optionally bar chocolate) Sweetener (granulated sugar, 0.6-2.4g trimoline, dehydrated glucose syrup) Cream 0.3-1.2 g Sodium Citrate(optional) 0.025-0.1 g Cocoa flavanol 3-300 mgs cocoa flavanolcontaining about 75% epicatechin and 25% catechin Collagen 1250 mgsLutein 25 mgs Silicic acid (Horsetail) 70 mgs Biotin 1.3 mgs Vitamin C10 mgs

EXAMPLE 3 Weight Loss Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 3a/b for a weight lossproduct, to deliver daily recommended or desired concentrations forweight loss and treatment of weight related related disorders anddiseases. Concentrations can be varied to provide the sameconcentrations in more than one serving.

TABLE 3a Inner Ice Cream Ingredient Amount per serving Low fat, lowcholesterol ice    5-20 g cream (e.g. mint) Appethyl 0.1-5.0 g

TABLE 3b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 g Calcium lactate <0.5 g Chocolate (cacao paste,1.0-4.0 g optionally bar chocolate) Sweetener (granulated sugar, 0.6-2.4g trimoline, dehydrated glucose syrup) Cream 0.3-1.2 g Sodium Citrate(optional) 0.025-0.1 g Stabilizer 0.025-0.1 g Appethyl 0.1-5.0 g

EXAMPLE 4 Skeletal Health Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 4a/b for a skeletal healthproduct, to deliver daily recommended or desired concentrations for bonemaintenance. Concentrations can be varied to provide the sameconcentrations in more than one serving.

TABLE 4a Inner Ice Cream Amount per individual Ingredient serving Icecream (e.g. chocolate) 5-20 g

TABLE 4b Membrane Amount per individual Ingredient serving SodiumAlginate 0.01-0.4 g Calcium citrate malate 200-1200 mg Magnesium citrate80-320 mg Vitamin D 500-4000 IU Water 3.0-12.0 Calcium lactate <0.5 gChocolate (cacao paste, 1.0-4.0 g optionally bar chocolate) Sweetener(granulated sugar, 0.6-2.4 g trimoline, dehydrated glucose syrup) Cream0.3-1.2 g Sodium Citrate (optional) 0.025-0.1 g Stabilizer 0.025-0.1 g

EXAMPLE 5 Cardiovascular Health Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 5a/b for a cardiovascularhealth composition to deliver daily recommended or desiredconcentrations for bioflavonoids, carotenes and essential fatty acidcompounds. Concentrations can be varied to provide the sameconcentrations in more than one serving.

TABLE 5a Inner Ice Cream Ingredient Amount per serving Non- or low-fatice cream  5-20 g (vanilla, chocolate) Life's Microencapsulated DHA 1000mgs

TABLE 5b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 g Calcium lactate <0.5 g Chocolate (cacao paste,1.0-4.0 g optionally bar chocolate) Sweetener (granulated sugar, 0.6-2.4g trimoline, dehydrated glucose syrup) Cream 0.3-1.2 g Sodium Citrate(optional) 0.025-0.1 g Stabilizer 0.025-0.1 g Lycopene 3 milligramsCocoa flavanols 250 milligrams

EXAMPLE 6 Joint and Cartilage Health Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 6a/b for a joint and cartilagehealth product, to deliver daily recommended or desired concentrationsfor joint and cartilage maintenance and treatment of related disordersand diseases. Concentrations can be varied to provide the sameconcentrations in more than one serving.

TABLE 6a Inner Ice Cream Amount per individual Ingredient serving Icecream (e.g. chocolate) 5-20 g

TABLE 6b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 Calcium lactate <0.5 g Chocolate (cacao paste, 1.0-4.0g optionally bar chocolate) Sweetener (granulated sugar, 0.6-2.4 gtrimoline, dehydrated glucose syrup) Cream 0.3-1.2 g Sodium Citrate(optional) 0.025-0.1 g Stabilizer 0.025-0.1 g Glucosamine Up to 2000 mgChondroitin Up to 2000 mg

EXAMPLE 7 Multivitamin Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 7a/b for a multivitaminproduct, to deliver daily recommended or desired concentrations formultivitamins and treatment for malnutrition and dietary imbalances.Concentrations can be varied to provide the same concentrations in morethan one serving.

TABLE 7a Inner Ice Cream Ingredient Amount per serving Chocolate icecream 5-20 g

TABLE 7b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 g Calcium lactate <0.5 g Chocolate (cacao paste,1.0-4.0 g optionally bar chocolate) Sweetener (granulated sugar, 0.6-2.4g trimoline, dehydrated glucose syrup) Cream 0.3-1.2 g Sodium Citrate(optional) 0.025-0.1 g Stabilizer 0.025-0.1 g AlternaVites ™ (for kids)2.5 g

AlternaVites for kids is a commercially available multivitaminsupplement composition labeled to contain 50% RDA vitamin A, 100% RDAvitamin C, 125% RDA vitamin D, 100% RDA vitamin E, 100% RDA thiamin,100% RDA riboflavin, 100% RDA niacin, 1005 RDA vitamin B6, 100% RDAfolic acid, 100% RDA vitamin B12, 17% RDA biotin, 100% RDA pantothenicacid, 15% RDA calcium, 100% RDA iodine, 10% RDA magnesium, 100% RDAzinc, and 50% RDA manganese, with other sweeteners and flavorings.

EXAMPLE 8 Essential Fatty Acids Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 8a/b for an essential fattyacid and dietary fiber product, to deliver daily recommended or desiredconcentrations for DHA for developmental health and dietary fiber forgastrointestinal health. Concentrations can be varied to provide thesame concentrations in more than one serving.

TABLE 8a Inner Ice Cream Ingredient Amount per serving Non-fat (vanilla)ice cream 5-20 g Life's Microencapsulated DHA  500 mgs

TABLE 8b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 g Calcium lactate <0.5 g Chocolate (cacao paste,1.0-4.0 g optionally bar chocolate) Sweetener (granulated sugar, 0.6-2.4g trimoline, dehydrated glucose syrup) Cream 0.3-1.2 g Sodium Citrate(optional) 0.025-0.1 g Stabilizer 0.025-0.1 g Dietary fiber (e.g.inulin) 3 grams

EXAMPLE 9 Branched-Chain Amino Acid Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 9a/b for BCAA (and glutamine)functional food product, to deliver daily recommended or desiredconcentrations bioavailable compounds for general health and wellness.Concentrations can be varied to provide the same concentrations in morethan one serving.

TABLE 9a Inner ice cream Ingredient Amount per serving Ice cream 5-20grams BCAA composition (Vitamin  3.5 grams Shoppe Body Tech BCAA +Glutamine product)

TABLE 9b Membrane Ingredient Amount per serving Sodium Alginate 0.01-0.4g Water 3.0-12.0 g Calcium lactate <0.5 g Sweetener (granulated sugar,0.6-2.4 g trimoline, dehydrated glucose syrup) Sodium Citrate (optional)0.025-0.1 g Stabilizer 0.025-0.1 g Mineral supplement blend, 10%-20% RDApowder form

EXAMPLE 10 Antioxidant Functional Food Composition

Membrane layer and inner compositions to be used in the functional foodcompositions can include various ingredients to achieve differentproducts (e.g., different flavors, textures and ingredients addressingspecific health purposes) based on the requirements or needs of theintended end user as well as recommended daily values or valuessufficient to achieve a health benefit, as described herein. An exampleof membrane layer composition and inner composition to be enclosed bythe membrane are provided below in Tables 10a/b for an antioxidantfunctional food product, to deliver daily recommended or desiredconcentrations bioavailable compounds for general health and wellness.Concentrations can be varied to provide the same concentrations in morethan one serving.

TABLE 10a Inner frozen yogurt Ingredient Amount per serving Frozenyogurt 5-20 grams Fiber  3-5 grams

TABLE 10b Membrane Ingredient Amount per serving Sodium Alginate0.01-0.4 g Water 3.0-12.0 g Calcium lactate <0.5 g Sweetener (granulatedsugar, 0.6-2.4 g trimoline, dehydrated glucose syrup) Sodium Citrate(optional) 0.025-0.1 g Stabilizer 0.025-0.1 g Vita-Veggie ® High-ORACfruit 1-2 grams and veggie blend Fresh fruit particles, chopped or 2grams minced

EXAMPLE 11 Functional Food Composition

Membrane layer and inner compositions to be used in the functionalnutrition transport systems can include various ingredients to achievedifferent products (e.g., different flavors, textures and ingredientsaddressing specific health purposes) based on the requirements or needsof the intended end user as well as recommended daily values or valuessufficient to achieve a health benefit. Various health benefits includeimproved immune response, improved vaccination response, modulatedhypersensitive immune response, cancer treatment, fungal infectiontreatment, etc. An example of membrane layer composition and innercomposition to be enclosed by the membrane are provided below in Tables11a/b for a β-glucan/probiotic nutritional product for use in enhancingimmunity.

TABLE 11a Inner Frozen Yogurt Amount per individual Ingredient servingFrozen yogurt (e.g. vanilla) 5-20 g Live probiotic: 10 BCFU, total(1-100 BCFU, L. acidophilus (Danisco optionally) HowAreU); Bifidus(Danisco) Heat treated probiotic: 10 mg Lactobacillus plantarum (HouseWellness Immuno20 HL L137)

TABLE 11b Membrane Amount per individual Ingredient serving SodiumAlginate 0.01-0.4 g β-glucan (Wellmune Biothera) 250 mg Water 1.0-4.0Calcium lactate <0.5 g Fruit/flavoring 1.0-15 g Sweetener 0.25-1.0 gSodium citrate (optional) 0.025-0.1 g Stabilizer 0.025-0.1 g

In general, an edible transport vessel can be made as follows. In a pot,combine 15 g sodium alginate and into 985 g of mineral water, then heatover a low heat until it simmers. Mix until alginate is completelydissolved and solution has a uniform consistency. Let set at 4° C. for2-3 hours. Add sugar, stabilizer, flavorings, and other membranecomponents to a final concentration desired for the individual transportvessels, and mix to a uniform consistency. Prepare a 2% calcium bath bymixing 20 g of calcium lactate with 1 liter water. Dissolve completely.Blend yogurt and sugar to consistent texture, and add to a pastry bag,piping bag or similar device. Dip end of pastry bag into inner membranealginate solution, and form small spheres of 1-2 inch diameter.Alternatively, frozen, preformed spheres of an encapsulated foodcomposition (e.g., frozen yogurt or ice cream with probiotic) can beplaced into the alginate solution, with or without a first calcium bathdip. Remove spheres from membrane alginate solution and place intocalcium bath for 10-15 minutes. Remove spheres and dry the surface withabsorbing paper. Store at 4° C. or −20° C.

While certain combinations of membranes and inner compositions have beenprovided and described as being used together, other combinations arepossible. It will be understood that various modifications may be madewithout departing from the spirit and scope of the invention.

1. A functional food composition, comprising: an edible or potablesubstance; a cross-linked edible matrix encapsulating the edible orpotable substance; a probiotic; and a prebiotic, with the proviso thatthe edible or potable substance and the matrix do not both contain theprobiotic or both contain the prebiotic.
 2. The functional foodcomposition of claim 1, wherein the matrix comprises the prebiotic andthe edible or potable substance component comprises the probiotic. 3.The functional food composition of claim 1, wherein the matrix comprisesthe probiotic and the edible or potable substance comprises theprebiotic.
 4. The functional food composition of claim 1, wherein thecomposition comprises a probiotic concentration from about 1.0 to about100 billion colony forming units in an individual edible transportvessel.
 5. The functional food composition of claim 1, wherein theprobiotic is an organism selected from the genera group consisting ofAspergillus, Bacillus, Bacteroides, Bifidobacterium, Brettanomyces,Enterococcum, Kluyveromyces, Lactobacillus, Lactococcus, Leuconostoc,Pediococcus, Propionibacterium, Saccharomyces, Shewanella,Streptococcus, Torulaspora, Vagococcus, and any derivatives, strains,and combinations thereof.
 6. The functional food composition of claim 1,wherein the prebiotic is one of the group consisting ofgalacto-oligosaccharides, inulin, oligofructose,isomalto-oligosaccharides, lactulose, lactosucrose,transgalacto-oligosaccharides, soybean oligosaccharides, tagatose,xylo-oligosaccharides, and combinations thereof.
 7. The functional foodcomposition of claim 1, wherein the composition comprises a prebioticconcentration from about 1.0 to about 30.0 grams in an individual edibletransport vessel.
 8. The functional food composition of claim 1, whereinthe matrix is comprised of an edible polymer charge cross-linked bymultivalent ions, including cross-linking interactions between theedible particles and edible polymer or plurality of edible polymers viabridges formed by the multivalent ions.
 9. The functional foodcomposition of claim 1, wherein the matrix comprises a polysaccharideselected from the group consisting of a hydrocolloid, shellac, andfibers.
 10. The functional food composition of claim 1, furthercomprising additional edible particles in the cross-linked matrix.11-17. (canceled)
 18. A method of preparing a functional foodcomposition, comprising the steps of: a) providing an edible or potablesubstance, an edible polymer, a probiotic, and a prebiotic; b) combiningthe edible or potable substance with the probiotic or the prebiotic; c)encapsulating the edible substance with the probiotic or the prebioticin an edible matrix that comprises the edible polymer and the probioticor the prebiotic; with the proviso that the edible or potable substanceand the matrix do not both contain the probiotic or both contain theprebiotic.
 19. The method of claim 18, further comprising cross-linkingthe edible matrix.
 20. The method of claim 18, wherein the prebiotic isin the matrix and the probiotic is in the edible or potable substance.21. The method of claim 18, wherein the probiotic is in the matrix andthe prebiotic is in the edible or potable substance.
 22. The method ofclaim 18, wherein the composition comprises a probiotic concentrationfrom about 1.0 to about 100 billion colony forming units in anindividual edible transport vessel.
 23. The method of claim 18, whereinthe probiotic is an organism selected from the genera group consistingof Aspergillus, Bacillus, Bacteroides, Bifidobacterium, Brettanomyces,Enterococcum, Kluyveromyces, Lactobacillus, Lactococcus, Leuconostoc,Pediococcus, Propionibacterium, Saccharomyces, Shewanella,Streptococcus, Torulaspora, Vagococcus, and any derivatives, strains,and combinations thereof.
 24. The method of claim 18, wherein theprebiotic is one of the group consisting of galacto-oligosaccharides,inulin, oligofructose, isomalto-oligosaccharides, lactulose,lactosucrose, transgalacto-oligosaccharides, soybean oligosaccharides,tagatose, xylo-oligosaccharides, and combinations thereof. 25-520.(canceled)
 521. The functional food composition of claim 1, wherein theprobiotic is a spore forming organism.
 522. The functional foodcomposition of claim 1, wherein the probiotic is an organism comprisingBacillus coagulans, and any derivatives, strains, and combinationsthereof.
 523. The method of claim 18, wherein the probiotic is anorganism comprising Bacillus coagulans, and any derivatives, strains,and combinations thereof.